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1554 24 December 1966 Working-time in General Practice-Eimerl and Pearson BREDICALTJSH, A Logan, R. F. L., and Eimerl, T. S. (1965). Millbank memn. Fd Quart., Peterson, 0. L., Andrews, L. T., Spain, R. F., and Greenberg, B. G.

43, No. 2, Pt. 2, pp. 302-310. (1956). 7. med. Educ., 31, No. 12, Pi. 2. pp. 1-165. Br Med J: first published as 10.1136/bmj.2.5529.1554 on 24 December 1966. Downloaded from Logan, W. P. D., and Cushion, A. A. (1958). G.R.O. Stud. on Med. and Querido, A. (1963). The Efficiency of Medical Cjie. Stenfert-Kroese. Pop. Sub;. No. 14, vol. 1, Morbidity Statistics from General Leiden. Practice. H.M.S.O., London. van der Wielen, V. (1960). M.D. Thesis: " The General Practitioner M\inistry of Healch (1965). Annual Report for 1964. H.M.S.O., London. and the Effectiveness of his Share in the Care of Health." Leiden. Appendix I nsiructions There is a separate form for each day ; please note the day Day of Week in the marked space on both sides of each form. Please note in the appropriate " box " the times of starting and of finishing a consulting session, round of visits, a particular visit-for VISITS example, night call, other work. To indicate number of patients seen during a session please mark the numerals (1-50 for that From K] to session) as each patient consults ; follow the same procedure for home visits. From L ] to Li Day of W CONSULTING-ROOM From L to [ Morning Afternoon Evening From Li to 1 26 f 1 26 1 26 2 27 L- 2 27 2 27 Time of 3 28 Time of 3 28 Time of 3 28 1 11 21 starting 4 29 starring 4 29 starting 4 29 2 12 22 5 30 5 30 5 30 3 13 23 6 31 6 31 6 31 4 14 24 7 32 7 32 7 32 5 15 25 8 33 8 33 8 33 6 16 26 9 34 9 34 9 34 7 17 27 10 35 10 35 10 35 8 18 28 11 36 11 36 11 36 9 19 29 12 37 12 37 12 37 10 20 30 13 38 13 38 13 38 14 39 14 39 14 39 HOSPITAL OR OTHER SESSIONS 15 40 15 40 15 40 16 41 16 41 16 41 17 42 17 42 17 42 From L to L 18 43 18 43 18 43 19 44 19 44 19 44 20 45 20 45 20 45 From Li to L 21 46 21 46 21 46 22 47 22 47 22 47 OTHER PROFESSIONAL DUTIES 23 48 23 48 23 48 Total time spent on other professional duties (other than that W I 24 49 fl 24 49 24 49 included above), e.g. telephoning, correspondence, contact with 25 50 L.-i25 50 j 25 50 other health workers. Time of Time of Time of finishing finishing finishing

minutes http://www.bmj.com/ Side I of Appendix. Side 2 of Appendix.

Methoxyflurane as an Obstetric : a Comparison with on 26 September 2021 by guest. Protected copyright.

VALERIE MAJOR,*t F.F.A. R.C.S.; AM. ROSEN, B F.F.A. R.C.S.; WILLIAM W. MUSHIN,* F.F.A. R.C.S.

Brit. med. J., 1966, 2, 1554-1561

The search for new methods and drugs to provide relief of addition to these methods or as the sole means of providing pain in continues. From the large number of new pain relief. Inhalational agents fulfil a particular role because techniques advocated (Lamaze, 195S ; Bullough, 1959 ; Heyns, of their evanescent effects and because they can be self- 1959; Cahal et al., 1961 ; Hingson et al., 1961 ; Davidson, administered. 1962 ; Crawford, 1963) it is clear that none is ideal and there The two inhalational agents widely used, and is yet room for improvement. Some methods, such as psycho- trichloroethylene, are of great value, though both possess certain prophylaxis, depend on adequate preparation in the antenatal disadvantages. Since this is so, any new inhalational agent period; others, such as caudal block, require the facilities of a deserves to be examined as a possible improvement. Preliminary hospital and the presence of a specially skilled doctor during clinical reports (Boisvert and Hudon, 1962 ; Romagnoli and labour-conditions which are unlikely to be fulfilled on all Korman, 1962; Johnstone, 1963) suggest that methoxyflurane occasions. Analgesic drugs are still widely used, either in is a useful and safe obstetric analgesic, though these reports do not show whether methoxyflurane has any advantage over the * Department of Anaesthetics, Welsh National Schoo! of Medicine, established agents. Our own trial was therefore designed to Cardiff. t Abbott Research Fellow. compare methoxyflurane with trichloroethylene. Trichloro- BRITISH 24 December 1966 Methoxyflurane-Major et al. MEDICAL JOURNAL 1555

was chosen because it is an already familiar analgesic, with constant flows of 8 litres per minute or more there was with physical characteristics somewhat similar to those of negligible lag between a change in the vaporizer setting and Br Med J: first published as 10.1136/bmj.2.5529.1554 on 24 December 1966. Downloaded from methoxyflurane. the change in the inhaled concentration. All concentrations given in this paper refer to actual inhaled concentrations and Administration of the Drugs not to vaporizer-scale settings. As well as adjusting the concentration of the vapour the A trial of a new drug usually requires two steps: the anaesthetist made continuous clinical observations and assess- optimum dose of the drug is determined, and then its effects ments, which were recorded immediately on a tape recorder. are compared with those of some other known drug. A com- parison between inhalational agents administered intermittently in fixed concentrations presents a particular problem. The Assessment dose the patient receives depends not only on the inspired con- centration but also very largely on what fraction the inter- The effects of the drugs were separately assessed by the mittent periods form of the whole duration of the inhalation. anaesthetist, by the midwife, and by the mother. These factors have made it necessary in previous trials to study large numbers of patients in order to obtain reliable results. We administered methoxyflurane and trichloroethylene con- Observations by Anaesthetist tinuously to avoid the difficulty presented by differences in the If an analgesic is to prove satisfactory, not only to the mother duration of intermittent inhalations. This method also enabled but also to the midwife and to the doctor, then other factors us to carry out two steps of the investigation simultaneously besides pain relief must be studied. They include the mother's in the following manner. The concentration of both vapours motor and emotional response to contractions, her motor and was varied according to the judgement of an experienced emotional between contractions, and her general level anaesthetist, with the aim of giving each patient the maximum of consciousness. These three factors provide the ingredients analgesia possible without causing undesirable side-effects. The of "good " analgesia. Each of them was separately and con- concentrations necessary to maintain this state must have been tinuously assessed by the anaesthetist throughout the period of those which were optimum for each patient. From a knowledge inhalation. The grading used for each was chosen during a of these concentrations the concentration likely to be suitable preliminary trial. All the assessments included in the results for intermittent inhalation might be predicted. This method were made by one anaesthetist. In practice it was not difficult also provides a basis for the comparison between the drugs, to choose a grade ; two of us scored some patients independently because it produces the most favourable response for each drug with complete agreement. These grades were further and therefore provides the highest number of satisfactory results grouped into "satisfactory " and "unsatisfactory "-terms which are in each of the groups. precisely defined below. Since the assessment of new is always difficult, and 1. Mother's Response to Contractions.-This provided objective the are results in obstetrics greatly influenced by the environ- evidence of the mother's behaviour during a contraction, and gives ment, antenatal care, and the personality of both mother and some indication of the pain felt. The grades used were: attendants, the drugs were compared under identical circum- stances. No response: lies quietly and shows no, The patients were divided into two groups by previously distress. These were regarded Slight response : grimaces, clenches her as satisfactory. randomizing the days for which each drug was used. The

fists, or moves slightly on the bed.) http://www.bmj.com/ trial was carried out in two hospitals, each with several labour larked response: groans, cries out, or rooms; many midwives were involved, making it difficult for them to identify the pattern of the experiment. Inhalation moves marKedly. These were regarded Uncontrolled response: cries, tosses as unsatisfactory. was started at the midwife's request, usually towards the end about, and is uncontrollable during of the first stage of labour. The patients in the trial were a contraction. chosen by the midwives but did not include any who had 2. Level of Consciousness.-This was graded as: attended classes in psychoprophylaxis or hypnosis. In addition Alert: eyes open, looks around, or holdsA the midwives tended to reserve the straightforward cases for a spontaneous conversation. teaching their pupils about inhalational analgesia. For these on 26 September 2021 by guest. Protected copyright. but when rerde Drowsy: lies quietly responds aThese reasons a cases high proportion of unbooked and difficult spoken to, talks with a normal voice, as satisfactory. deliveries are included in this trial, and the two drugs were and obeys any commands promptly.) compared under particularly testing conditions. Very drowsy: slurred speech and slug- A record was kept of the dose and time of administration of gish response to command. These were regarded other drugs during iabour ; no direction or restriction was made Semiconscious: roused only by strong as unsatisfactory. regarding their use. stimuli.

Methoxyflurane and trichloroethylene were vaporized in 3. Restlessness.-Some patients were restless, fretful, or noisy between contractions. Restlessness was as: Pentec and Tritec made identical in appearance. Each graded vaporizer had a scale from 0.1% to 1.5% in steps of 0.1%. Not restless: lies quietly between con- This was regarded tractions. as The were vaporized by and air from an injector, satisfactory. Restless : complains, is fretful, excitable, This was regarded and the issuing vapour mixture was collected in a reservoir or distressed between contractions. as unsatisfactory. bag, from which the patient inhaled through a non-return valve. The inhaled concentration of oxygen was 36% to 40%, which Analysis of Anaesthetist's Observations.-Graphs were plotted was regarded as a safety factor in this investigation. The for each patient to show the periods of time during inhalation vaporizer scale was mechanically linked to a simple electrical which were classified as "satisfactory" for the three separate circuit, so that the concentration indicated on the scale was factors. These periods were expressed as a percentage of the continuously recorded by a pen recorder. total time of inhalation (Fig. 1). There are periods when the The vaporizers were calibrated by us, using a katharometer, response to a contraction was satisfactory, though one or both and were checked frequently throughout the trial. A graph of the other two factors were unsatisfactory. In practice it is was constructed to show the actual inhaled concentration at only when all three factors are simultaneously satisfactory that each vaporized-scale setting for various flows. Though the objective of good analgesia is approached. These periods both drugs are soluble in rubber our investigations showed that are shown in Fig. 1 as "all factors satisfactory " and are BRrrisH 1556 24 December 1966 Methoxyflurane-Major et al. MEDICAL JOURNAL

Sxressed as a percentage of the total duration. All factors ethylene was 1 hour 17 minutes. (P>0.60). The two groups satisfactory takes into account the anaesthetist's assessment of are therefore comparable. Labour was well established in all Br Med J: first published as 10.1136/bmj.2.5529.1554 on 24 December 1966. Downloaded from =ree aspects of the patient's behaviour in labour, providing a cases before inhalation was started. The longest period between -easonable overall picture of the effectiveness of the drug as any two contractions in the whole series was six minutes ; in mn obstetric analgesic. This method of quantifying the results the majority of cases it was two to three minutes. nables a comparison to be drawn between the two groups of Iatsents. Observations by Anaesthetist RESPONSE TO CONTRACTIONS I).-The percentage of time NONE - Del ivery All Factors Satisfactory (Table SNLIGHT -] SATISFACTORY for all factors satisfactory was determined for each patient and MARKED - "L Y NOT the mean for each group calculated. The mean time for UNCONTROLLED7Ji SATISFACTORY trichloroethylene was 47.7% and for methoxyflurane 60.3%. longer ALERT LEVEL OF CONSCIOUSNESS S The methoxyflurane group was satisfactory significantly DROWSY tSATISFACTORY than the trichloroethylene group. TOO DROWSY - NOT SEMICONSCIOUS - SATISFACTORY TABLE I.-Percentage of the Duration of Inhalation Regarded as REST LESSNESS Satisfactory NOT RESTLESS -L ~~~~~~SATISFACTORY Mean Percentage of Time Significancz Satisfactory RESTLESS - SATISFACTORY Factor Studied Trichloro- b Aethoxy- ethylene flurane S.D.* P ALL FACTORS SATISFACTORY = 72-70/% OF TIME (21 Patients) (25 Patients) _ _ ___ OF INHALATION A All factors satisfactory 47-7 %', 603° 5.8 < 0-05

Reaction to contractions -.30-8 0 20 40 60 80 Restlessness satisfactory 89-2'0O 96O0° 3-6 <01 MINUTES = Standard deviation. !rG. I.-Illustration of the method used to derive the percentage of time *S.D. all factors satisfactory." Reaction to Contractions (Table I).-Patients who received methoxyflurane were satisfactory as regards this factor for more Opinion of Midwife of the time (71.8 %) than the patients receiving trichloroethylene The midwife was asked just after delivery: (61.8 C) This difference is nearly significant. Do you consider that the analgesia was-complete/consider- Level of Consciousness (Table I).-No patient in the trial able/slight/none ? became unconscious. The percentages of the time that the level almost identical for the the 'was-too drowsy/satis- of consciousness was satisfactory were Do you consider that patient two drugs. This indicates that the aim of limiting the con- factory ? centration before the patients became too drowsy was achieved. Do you consider that the patient was-restless/satisfactory ?" Both drugs appear to have been " pushed " to the same extent. Restlessness Between Contractions (Table I).-Though the percentage of time during which this factor was satisfactory Ouinion of Mother was high for both drugs, the presence of restlessness between http://www.bmj.com/ The mother was questioned twice-at 15 minutes after contractions is an undesirable feature, interfering with the 1i:iivery and then later at 36-48 hours. She was asked: " Do management of labour, and the presence of this in any degree you consider that what you had to breathe helped you- cannot be overlooked. From this standpoint trichloroethylene .mpletely/considerably/slightlv/not at all ?" is less satisfactory than methoxyflurane. In the case of cf for 10.8 % of the visit were asked trichloroethylene the patients were restless !n addition, at the second questions for it was 4 %-a difference which and other side-effects. time, whereas methoxyflurane ctarding nausea, memory, is almost significant. All Factors Satisfactory for each Half-hour Period.-The on 26 September 2021 by guest. Protected copyright. .Assessment of Baby previous calculations are based on the mean for the whole period of inhalation. The comparison between the drugs could The anaesthetist assessed the and noted the have been biased by such factors as the duration of inhalation me in minutes to the onset of regular respirations. and the stage of labour. To determine whether this was so the times of inhalation for each patient was divided into half-hour periods. The time when all factors were satisfactory is Results expressed as a percentage of each half-hour period throughout the inhalation. The frequency distribution (Table II) shows orty-six patients were given inhalational analgesia in this that in the methoxyflurane group 16 % of the periods were ,rial. Twenty-one had trichloroethylene (9 primigravidae, 12 satisfactory for over 90%O of the time and 57% for over 60%/' 2'ultigravidae) and 25 had methoxyflurane (8 primigravidae, of the time. The corresponding figures for the trichloroethylene 17 multigravidae). In four cases (two in each group) inhalation group are 90O and 38%, which are significantly lower. was stopped before delivery for obstetric causes (i.e., caesarean section or forceps under ), and in two cases TABt E I.-Distribution of Half-hour Periods According to the Percentage at the patient's request (both these in the trichloroethylene of Time All Factors Satisfactory group). Percentage of Time All Factors Satisfactory Drug 0- 21- 41- 61- 71- 81- 91- Total 20 40 60 70(_80 90 100 Duration if Labour 6 15 12 4 6 6 5 54 No. of jf Trichloro-ethylene (lI %) (28%) (220%) (7 "') (11%) (9%) (100%) the half-hour Methoxy- 13 6 12 14 10 6 12 73 The shortest period of inhalation was 15 minutes and periods flurane (18o/) (8%) (16%) (190%)I(14%) (8%) (16%) (100% longest 3 hours 40 minutes. The mean duration for methoxy- ifurane was 1 hour 25 minutes and the mean for trichloro- x9=13.9. P 03 10-6. <005 15-6. > 04 93. <005 Mothers' Trichloro- -I I- assessment at ethylene 2 (10%) 17 (80%) 0 2 (10%) 0 36-48 hours Methoxy- after delivery flurane 8 (32%) 16 (64%) 1 (4%) 0 0 Effect of on All Factors Satisfactory.-Approxi- mately half the patients in each group had pethidine during the four hours preceding inhalation (13 in the methoxyflurane Assessment of Pain Relief at 36-48 Hours.-Thirteen group and 10 in the trichloroethylene group). Pethidine had mothers changed their opinion at this second questioning-five only a small effect on all factors satisfactory in either group had received trichloroethylene and eight methoxyflurane. Of (Table IV). The differences shown between trichloroethylene these 13 nine changed up a single grade, and four changed and methoxyflurane were not due to the administration of down a single grade. There was no association between those pethidine. who changed their mind and the vapour used. At this assess- ment the number of patients who thought that the pain relief TABLE IV.-Effects of Pethidine on All Factors Satisfactory was complete or considerable was 96% for the methoxyflurane group and 90% of the trichloroethylene group. The number Mean Percentage of Time All Factors Satisfactory. who replied complete was significantly higher in the group who http://www.bmj.com/ DrugDrug PatientsNo. of PethidinePrecedingduringInhalation4 Hours Significance had received methoxyflurane (P=0.05) (Table VI). The two mothers who said "no help" were both receiving trichloro- Yes No IS.D.I P I- ~ ~ ,_ ethylene. One complained throughout 30 minutes of inhalation Trichloroethylene 21 48-9% of time 46-4% of time 9.3 >08 Methoxyflurane 25 61-8%,, ,, 58 8%,, that she was receiving no pain relief at all, and refused to 78 >0-6 continue. The other complained of nausea, and did not wish to continue the inhalation. This change of opinion emphasizes the importance of stating the times of questioning in relation to delivery. Opinion of Midwife Memory of Labour and Delivery.-(Table VII).-At this on 26 September 2021 by guest. Protected copyright. The midwives thought the analgesia to be considerable in assessment the mothers were also asked, " Was your memory of 91% of each group. This assessment showed no significant labour after you started breathing the mixture-clear/hazy/ difference between the two drugs (P>0.30). none ? " The same question was asked about delivery. These The midwives' assessment of the level of consciousness was answers showed no significant difference between the cfrugs. that more patients were drowsy when methoxyflurane was used, With both drugs there is a high correlation between those but there was no significant difference between the two groups patients who had a hazy or no memory of labour and those (Table V). TABLE VII.-Mothers' Memory of Labour and Delivery TABLE V.-Msdwives' Opinion of Level of Consciousness and Mothers'Memory Significance. Restlessness Drug Clear v. Other Clear Hazy None Replies Satis- Unsatis- Cannot Satisfactory v. Drug Labour f Trichloroethylene 11 (52%) 9 (43%) 1 (5%) factory factory Assess Other Replies Methoxyflurane .. 10 (40%) 15 (60%) 0 } P >03 _.i- -I- I I - f Trichloro- Delivery* Trichloroethylene.. 11 (65%) 6 (35%) 0 } P>05 Level of ethylene 20 (95%) 0 1(5%) Methoxyflurane 15 (65%5 7 (30%) 1 (5%) consciousness Methoxy- P<03 { flurane 22 (88%) 2 (8%) 1(4%) * Inhalation stopped before delivery in 6 patients. Trichloro- 15 (70%) 6 0 Restlessness Methylene (30%) P<0.-03 TABLE VIII.-Correlation Between, Change of Mothers' Assessment ot flurane 24 (96%) 0 1 (40' ) Pain Relief and Memory of Labour Changed Same No. of Assessment Assessment Patients More patients in the trichloroethylene group were thought to Memory clear .. .. 2 19 21 be restless (Table V). None of the patients receiving methoxy- ,, hazy or none* 11 12 23 flurane was to thought be restless. This difference is significant. * 2 patients not questioned immediately after delivery. P < 0-01. B BRITsH 1558 24 December 1966 Methoxyflurane-Major et al. MEDICAL JOURNAL who changed their assessment of the analgesia at the second group 63 0/. of the babies had established respiration within one questioning (Table VIII). This shows that the effect of the minute, compared with 72 % in the methoxyflurane group Br Med J: first published as 10.1136/bmj.2.5529.1554 on 24 December 1966. Downloaded from drug on memory is mainly responsible for the changes in the (P>0.20). The three stillbirths were diagnosed as foetal deaths mothers' opinion. before inhalational analgesia had started. Other Effects of the Drugs (Table IX).-Smell of vapour: Seven mothers noticed the smell of but TABLE XI.-Distribution of Apgar Score for Babies of Mothers methoxyflurane, only Receiving Inhalation Analgesia up to Delivery one found it unpleasant. The smell of trichloroethylene was noticed by two mothers but both regarded it as unpleasant. Apgar Score % of Babies Drug with Score Nausea and vomiting: Three patients receiving trichloro- Drug______10 9 8 7 6 5 4 3 2 1 of 8 or More ethylene complained of nausea. One of these had such severe *No. of (Trichloroethylene 5 5 2 2 1 0 0 0 1 0 75 nausea that the inhalation had to be stopped. Two patients in babies i'Methoxyflurane 5 110 3 1 1 2 0 0 0 0 82 the group were methoxyflurane nauseated. The patient *3 stillbirths excluded. receiving trichloroethylene who vomited did so during labour. Z2=0-26. P O.5. The two patients in the methoxyflurane group who vomited did so after delivery. Concentrations of Methoxyflurane and Trichloroethylene TABLE IX.-Other Effects of the Drugs From the continuous recordings of the inhaled concentrations Question Trichloroethylene Methoxyflurane Significance of the drugs the mean concentration for each consecutive 15- " Yes " " Yes " I~~~~~~-I- minute period was calculated. The means of these concentra- Did you notice the smell? 10% 28% P0-3 (3 of 21) (2 of 25) TABLE XII.-Mean Inhaled Concentrations of Trichloroethylene and Did you vomit? 5% 8% P>0-8 Methoxyflurane for Consecutive 15-minute Periods (1 of 21) (2 of 25) Was it worse than you 48% 24 %O P

more satisfactory in the methoxyflurane group. ix z TRICHLOROETHYLENE

w 03 http://www.bmj.com/

z 0 Other Criteria U 0-2- w Mode of Delivery.-The modes of delivery are shown in METHOXYFLURANE Table X. z 0I1 -

z TABLE X.-Mode of Delivery 0 No. of Patients 0 i5 30 45 60 is 90 Mode of Delivery MINUTES on 26 September 2021 by guest. Protected copyright. Trichloroethyleneyh Methoxyflurane ..l FIG. 2.-Mean inhaled concentrations of trichloro- Spontaneous vertex 12* 18t ethylene and methoxyflurane for consecutive 15- Forceps 3t 5t minute periods. Breech 5 2 Caesarean section it 0 TABLE XIII.-Mean Number of Changes in Concentration for Consecutive 15-minute Periods Includes 2 mothers in whom inhalation was stopped before delivery. t Includes mother in whom inhalation was stopped before delivery. Mean No. of Changes in Concentration for Consecutive 15-minute Periods from Start of Inhalation Blood Pressure and Pulse.-No untoward effects on the pulse or blood pressure were seen in either group. Ventilation.-Each contraction was accompanied by hyper- ventilation followed by some hypoventilation. At the beginning of labour there was a tendency for some mothers to hyper- ventilate continuously, probably because they were breathing through a mask, but they invariably stopped doing this once we had explained that it was unnecessary. The number of changes in concentration made by the anaes- Condition of Banes.-No changes in the foetal thetist during each case was also counted and the mean number were noted that could be associated with either vapour. The for each drug calculated (Table XIII). Throughout the only case of foetal distress in the series was the patient who administration with trichloroethylene a similar number of came to caesarean section; the cause was a placental insuffi- adjustments were required to keep the state of the patient steady, ciency. The number of babies with Apgar scores of 8 or more while with methoxyflurane the number of changes necessary showed no significant difference between the drugs (Table XI). became fewer as the case proceeded. These differences were The baby with an Apgar score of less than 5 was a case of significant for the third, fourth, and sixth 15-minute periods difficult assisted breech delivery. In the trichloroethylene from the start of inhalation. BR ysH 24 December 1966 Methoxyflurane-Major et al. MEDICAL JOURNAL 1559

The assessment of the drugs should also take into Clinical Observations objective Br Med J: first published as 10.1136/bmj.2.5529.1554 on 24 December 1966. Downloaded from account other effects that may interfere with the conduct of to our did not to Contrary expectations the patients object labour or the safety of mother and baby. These effects are none about a mask inhaling continuously; protested having principally concerned with the mother's behaviour in labour- over her for the The first face whole period of inhalation. whether she is capable of looking after herself, and whether she breath of was a since in this vapour given during contraction, is fully co-operative with the midwife. In previous trials fewer commented on the smell. way patients (Minnitt, 1934; M.R.C., 1954) the midwife had been ques- Methoxyflurane appeared to have a marked action. tioned about the relief of pain; her answer was probably based Many patients receiving it lay quietly with eyes closed, but on her overall observations of the patient's behaviour during readily took part in conversation and co-operated. Several labour. Though the mother's behaviour during contractions is commented on the fact that they could feel the pain of con- often evidence of the pain felt, this is not always so, making it traction but felt they were dissociated from it-as one patient unlikely that the midwife's single retrospective opinion of the said, " I am floating along separately from the pain." pain relief is reliable. For these reasons, if the midwife's opinion Overdose with methoxyflurane usually showed itself by the about the analgesia is to be of value it should be used as a patients becoming too sleepy and not easily rousable, while in guide to the patient's behaviour during contractions rather than the case of trichloroethylene they usually became restless and as an estimate of her pain relief. confused. The patient's behaviour between contractions is also impor- tant, and the midwife can observe and give evidence about this too. Information obtained by retrospective questions regarding Discussion the mother's behaviour was sought in one recent trial (McAneny and Doughty, 1963), but their report did not show for how This method of in which the concentration administration, long the patients were noisy, restless, or uncooperative, or is to suit each results in a continuously adjusted mother, high whether they were also the same patients who were dissatisfied of a favourable to the proportion patients having response drugs with the relief from pain. Our continuous method of assess- because the effect of variation of to a biological individuals ment takes into account both the patient's ability to co-operate fixed dose is eliminated. It thus the truest largely provides and an objective estimate of her pain relief. A single factor is between the of each A comparison potential capabilities drug. derived relating these to each other and measuring the per- reliable indication of this can be obtained with fewer patients centage of the time of inhalation for which we considered all than if several fixed concentrations are used. factors satisfactory. This enables a comparison to be made We were aware that bias might have influenced the changes between the drugs. made in since we were unable to devise a sure concentrations, Our results show that methoxyflurane is likely to prove a method of from the anaesthetist which was in concealing drug better obstetric analgesic than trichloroethylene. The mothers use. the trial was blind to the midwife and However, mother, found that the analgesia with methoxyflurane was significantly and therefore to some extent their assessment is a check on better than with trichloroethylene. The midwives found that the of bias in the anaesthetist's administration. presence any the restlessness with methoxyflurane was significantly less than The mothers' assessments show that the was better analgesia with trichloroethylene, and that drowsiness was only slightly with than with The mid- methoxyflurane trichloroethylene. greater with methoxyflurane than with trichloroethylene. They wives' assessments show that the undesirable side-effects of thought that the analgesia with both drugs was considerable were less than those of methoxyflurane trichloroethylene. (over 90%), but seen through their eyes in this respect the drugs These assessments indicate that the anaesthetist is to http://www.bmj.com/ unlikely were indistinguishable. have shown any bias against trichloroethylene. If the con- The anaesthetist's assessment shows that the overall period of centration of trichloroethylene had been "pushed " in an time when the was observed to be satisfactory for attempt to increase the analgesia, even more side-effects would patient all have been observed than before. Conversely, if the concentra- factors was 60.3% for the methoxyflurane group and 47.7 % for the trichloroethylene group. The patients who did not tion of trichloroethylene had been kept lower in an attempt to reduce the incidence of side-effects, then the discrepancy satisfy the midwives for any reason correlate well with those between the analgesia produced by the two drugs would have patients who are at the lower end of the anaesthetist's grading Our is more been even of all factors satisfactory (Fig. 3). scale, however, greater. on 26 September 2021 by guest. Protected copyright. sensitive than that of the midwives, and the anaesthetist was Detailed and continuous individual recordings provided better able to discriminate between the effects of the drugs. further evidence and confirm that each change in the patient's The anaesthetist's assessment of all factors satisfactory bears state corresponded to a change in the inspired concentration. For a close relation to the mothers' opinion (Fig. 4). This indicates example, a marked reaction to a contraction resulted in the that there is a good degree of correlation between our method anaesthetist increasing the inhaled concentration, and an excess of assessment and the mothers' subjective opinion. of drowsiness or restlessness resulted in a lowering of the inhaled concentration. If the anaesthetist had been biased then Though our results show that methoxyflurane represents an either it would be obvious that not enough effort had been advance over trichloroethylene in the circumstances of our trial, made to achieve a satisfactory state or that the changes that l zMETHOXYFLURANE were made were too large. All observations were made by one anaesthetist to eliminate observer differences. S TRICHLOROETHYLEN Bias might also have been communicated to the patient, and to minimize this a series of questions with multi-choice answers 8 MIWIV; ;SoASFIED were used. These were read to each mother and midwife in an even voice, when asking for her assessment. Beside the problem of bias, the actual assessment of obstetric pain relief is not a simple matter. In so far as the subjective TIME sensation of pain is concerned, the mother's opinion is the only one that counts. This is not an opinion, however, purely assess- O'~~ ~ ~ ~ ~ ~ ~ ~~ ment of the drug under investigation but is influenced by the mother's physical and emotional environment. For these : fIDW.IES- NC SAT-isfy - reasons, both drugs were administered in an identical manner FIG. 3.-Comparison between the assessments made by the midwives and in the same maternity hospitals to provide similar backgrounds. the anaesthetist (derived from Table V). 1560 24 December 1966 Methoxyflurane-Majoi- et al. MEDICALTJOsRNAL our scale of assessment was so stringent that even in the case Summary of methoxyflurane we considered all factors satisfactory for Br Med J: first published as 10.1136/bmj.2.5529.1554 on 24 December 1966. Downloaded from only 60% of the time. There is therefore still room for Methoxyflurane and trichloroethylene have been compared improvement. We must also stress that our results relate only as obstetric analgesics, taking into account the mother's to the special conditions laid down for this trial (i.e., the con- behaviour as well as her relief from pain. Each vapour was tinuous administration of the drugs by an anaesthetist who was administered continuously by an anaesthetist, who varied the present throughout inhalation and adjusted the concentration inhaled concentrations to produce the least reaction to a for each patient). The inhaled concentrations were accurately contraction compatible with co-operative behaviour. The known; this too may prove important, since variations between degree to which this state can be maintained is a measure of a individual vaporizers and their dependence on flow and tem- drug's potential as an obstetric analgesic, and provides a prac- perature can introduce large errors. tical basis for a comparison. This assessment was made by one anaesthetist, who continuously graded the reactions and behaviour 8 Q METHOXYFLURANE of the mothers both during and between contractions. 7 S TRICHLOROETHYLENE From these recorded observations a single value was derived Vn6- relating them to the duration of the inhalation. This value- "all factors satisfactory "-measured the percentage of the MOTHERS SATISFIED time of inhalation during which all the criteria were fulfilled. 4 rC ofsIdtrabl" or This assessment showed that methoxyflurane was significantly better than trichloroethylene. FIG. 4.-CopisteU E F m imon 2 a Besides the anaesthetist the assessors included the mother WI and the midwife, for whom the trial was blind. The mothers' V_ __ ~~~~~~~~~~TIME 0 A_1 I "~~~~~'ALL FACTORS o go .1 '3 40 59 70 SO 90/0 SATISFACTORY" assessment (at 36-48 hours) showed that a significantly higher Z0 TO number of the group having methoxyflurane considered the pain I ~~~~~~~~~~~ANAESTHETIST relief complete. The midwives' assessment was that methoxy- flurane caused significantly less restlessness than MOTHERS NOT SATISFIED trichloro- ("SlIIght~or"none") ethylene. They thought methoxyflurane produced more FIG. 4.-Comparison between the mothers' immediate opinion and the drowsiness, but this difference was small. They could not dis- anaesthetist's assessment. tinguish between the relief of pain provided by the drugs. The From a comparison of the curves of the mean inhaled con- curve of the mean inhaled concentration against time for centrations of both drugs methoxyflurane follows a predictable pattern, on the assumption it was deduced that methoxyflurane that the blood concentrations were was suitable for intermittent administration and that initial approximately steady; that studies should start with a single fixed inhaled concentration of of trichloroethylene does not. (The ventilation was similar in 0.35%. both groups of patients.) In Fig. 2 the curve for trichloro- ethylene is steeper than that for methoxyflurane. From theoretical curves (Mapleson, 1963) which take account of the Appendix breakdown of trichloroethylene in the body it can be derived The mean inhaled concentrations of each drug varied with that, on the same assumption, the curve for trichloroethylene time (Fig. 2). Over a period of one and a half hours the mean should be even less steep than that for methoxyflurane. The concentration of trichloroethylene fell from 0.4% to 0.08 % (a discrepancy is almost certainly due to the effects of the break- ratio of 5:1), and the concentration of methoxyflurane fell from down products of trichloroethylene- hydrate and 0.32% to 0.16% (a ratio of 2:1). The steeper slope of the http://www.bmj.com/ trichlorethanol (Butler, 1949). These substances have been trichloroethylene curve is probably the explanation of why two shown to cause restlessness in the presence of painful stimuli fixed concentrations of the drug were originally found neces- (Sharpless, 1965). Since the anaesthetist was aiming at the sary; a concentration high enough to satisfy a reasonable pro- greatest degree of analgesia compatible with a co-operative portion in the first half-hour would be too high for many in patient, restlessness would encourage a reduction in the inhaled the subsequent half-hour. The flatter slope of the methoxy- concentration of trichloroethylene. Thus the effect of the flurane curve makes it probable that for intermittent administra- known breakdown products of trichloroethylene leading to rest- tion only one fixed concentration would be necessary. lessness is the probable explanation of the unexpectedly rapid A single concentration of methoxyflurane should clearly be on 26 September 2021 by guest. Protected copyright. reduction in the inhaled concentration of trichloroethylene, to less than the concentration of trichloroethylene now used by a degree far greater than would be expected if a steady blood midwives. We believe that a reasonable way of arriving at a concentration was to be maintained. suitable figure is to multiply the established figure for trichloro- Besides the greatly reduced incidence of restlessness with ethylene by the ratio of the mean concentrations of the two methoxyflurane, we noted the sedative effect also reported by drugs used in this investigation (Table XII). We therefore others (Johnstone, 1963). If this observation is borne out in recommend a single inhaled concentration of methoxyflurane larger surveys, it would show that methoxyflurane possessed a 0.22 positive advantage. of 0.5 x 0.30 =0.35%." for initial trial. It is likely that the difference seen between the two drugs when administered continuously would be maintained when We wish to thank our obstetric colleagues and the midwives at they were given in fixed inhaled concentrations of comparable the Maternity Hospital, United Cardiff Hospitals, and the Maternity potency, since the standard deviations of the mean concentration Unit, St. David's Hospital, Cardiff, for their help and collaboration of each vapour are close (Table XII). We would recommend during this trial. We would also like to acknowledge the useful a single inhaled concentration of 0.35% of methoxyflurane for comments and criticisms of W. W. Mapleson, Ph.D., and other an initial trial by intermittent inhalation (see Appendix). colleagues. This work was supported by a grant from Ltd. The vaporizers were kindly loaned by Cyprane We would also recommend that all inhalers have an " off" Ltd. and Longworth Scientific Ltd. (Penlon). position. If a mother has received too much vapour it is often difficult to persuade her to relinquish the mask, especially if she REFERENCES has found the inhalations helpful. Turning the vaporizer Boisvert, M., and Hudon, F. (1962). Canad. Anaeszh. Soc. 7., 9, 325. off is much easier and patients do not usually notice this Bullough, J. (1959). Brit. med. 7., 2, 859. until some time has elapsed, usually when it is time to Butler, T. C. (1949). 7. Pharmacol. exp. Ther., 97, 84. turn Cahal, D. A., Dare, J. G., and Keith, D. (1961). 7. Obstet. Gynaec. Brit. it on again. Cwlth, 68, 88. 24 December 1966 Methoxyflurane-Major et al. RDITJOUIRAL 1561 Crawford, J. S. (1963). Brit. med. 2, 119. Mapleson, W. W. (1963). In Uptake and Distribution of

Y., Br Med J: first published as 10.1136/bmj.2.5529.1554 on 24 December 1966. Downloaded from Davidson, J. A. (1962). Ibid., 2, 951. Agents, edited by E. M. Papper and W J. Kitz, P. 104. New York. Heyns, 0. S. (1959). 7. Obstet. Gynaec. Brit. Emp., 66, 220. Medical Research Council (1954). The Use of Trilene by Midwives, Hingson, R. A., Cull, W. A., and Benzinger, M. (1961). Anesth. Anaog. Memorandum No. 30. London. Curr. Res., 40, 119. Minnitt, R. J. (1934). Brit. med. Y., 1, 501. Johnstone, M. (1963). Proceedings of the Symposium on Methoxyflurane, Romagnoli, A., and Korman, D. (1962). Canad. Anaesth. Soc. Y., 9, 414. p. 35. Queensborough, Kent. Sharpless, S. K. (1965). In The Pharmacological Basis of Therapeutics, Lamaze, F. (1958). Painless Childbirth. London. edited by L. S. Goodman and A. Gillman, 3rd ed., p. 132. New McAneny, T. M., and Doughty, A. G. (1963). Anaesthesia, 18, 488. York.

Patients who Reside in Common Lodging-houses

RICHARD SCOTT,* M.D., D.P.H.; P. G. GASKELL,* M.B., CH.B. D. C. MORRELL,* M.B., B.S., M.R.C.P., D.OBST.R.C.O.G.

Brit. med. Jt., 1966, 2, 1561-1564

Common lodging-houses exist in many of our larger cities and The sample used for this study simply consisted of all patients are licensed by the local health authority. A night's lodging residing in common lodging-houses who so presented themselves i4 cheap and the facilities provided are correspondingly limited. during a period of six months (March-August 1964). This Many clients pay for one night at a time. consecutive series of 310 persons comprised 210 who had There is surprisingly little up-to-date information about the attended on at least one previous occasion, together with 100 size of the lodging-house population in this country, and its who were seen for the first time ever during the period of the demands and needs in respect of medical or social care. Laid- survey. law (1956) traced the growth of the lodging-house system. He Two categories of data were collected during the survey: made a detailed study of lodging-houses in Glasgow, which at (1) information recorded in respect of each person on the first that time accommodated over 7,000 persons, of whom he occasion on which he was seen during the period; and (2) data interviewed 800. Sargaison (1954) surveyed living conditions recorded at each consultation with each patient throughout in lodging-houses in Belfast, and reported on the results she the survey period. obtained from a social interview with a series of 371 inhabitants The of the information available to the doctor at the over the age of 60 years. Merfyn Turner (1960) gave an first consultation varied; in respect of the new patients no interesting commentary on a London lodging-house and some information at all existed, but with regard to two-thirds of the of Its inhabitants as seen by a trained sociologist. We require sample at least some information was available before the patient a considerable investment in sociological and epidemiological was seen for the first time during the period. techniques if we are to bring these studies up to date and to It is appreciated that severe limitations are imposed on the http://www.bmj.com/ extend them. significance which can be attributed to data derived from a Clinical studies relating to the lodging-house population general practitioner's consulting-room in respect of a hetero- usually reflect the specialist's interest-for example, Whiteley geneous group of persons, many of whom are already selected (1955) reported on the psychiatric diagnosis of 100 men by virtue of consulting a doctor. At the same time, the informa- admitted to an observation ward from three lodging-houses in tion relating to this consecutive series of patients is so striking London, while Edwards et al. (1966) studied alcoholism in a that it was thought to be worth publishing at this stage. We sample group of 51 down-and-out men who were regular hope by this means to interest others who may be working in patrons of a soup kitchen in Stepney. parallel fields and may be able to assist us in the extension of on 26 September 2021 by guest. Protected copyright. General practitioners and hospital doctors working in casualty our studies. and outpatient departments not infrequently encounter indivi- duals residing in common lodging-houses. Since they see a broader spectrum of disease than that presenting in more Method of Assessment at First Attendance specialized departments, it is worth while to look at records which can be obtained from such sources. On the occasion of the first attendance at the surgery during the study period certain social and clinical data were recorded in a standard fashion. Method The social data included the patient's name, age, sex, civil The Sample status, religion, length of stay in lodging-house, contact with other relatives, occupation, occupational state, and source of This study took place in a general practice in Edinburgh. income. In that city there exists lodging-house accommodation for approximately 1,000 persons. Five lodging-houses are situated The clinical data were obtained by a rigidly standardized within a radius of a quarter of a mile of the practice premises, history-taking. Because of his dual role of providing medical and, though their occupants are free to consult any doctor in care and taking part in a planned survey the doctor was, the area, substantial numbers of them use this practice. As a however, free to supplement this questionary and to carry out consequence, and some time before the study began, when the such physical examination as he regarded as clinically rele- practice reorganized its appointment system we reserved one vant to the patient's presenting symptoms. He was also, hour each morning during which individuals residing in com- of course, free to use information acquired in respect of those mon lodging-houses could present themselves as temporary patients who had already been seen at some time before the patients without prior appointment. survey began. The clinical impression derived from years of experience with * Department of General Practice, Edinburgh University. lodging-house patients was that there is an unusually high inci-