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Double-Blind Crossover Trial of Oral Meptazinol, Pentazocine and Placebo in the Treatment of Pain in the Elderly V

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Double-Blind Crossover Trial of Oral Meptazinol, Pentazocine and Placebo in the Treatment of Pain in the Elderly V Postgrad Med J: first published as 10.1136/pgmj.56.657.474 on 1 July 1980. Downloaded from Postgraduate Medical Journal (July 1980) 56, 474-477 Double-blind crossover trial of oral meptazinol, pentazocine and placebo in the treatment of pain in the elderly V. PEARCE P. J. ROBSON M.B. B.S., M.R.C.P. M.B. B.S., M.R.C.P. Chesterton Hospital, Cambridge and Wyeth Laboratories, Maidenhead, Berkshire Summary unit, pentazocine 25 mg orally, and placebo. The 2 In a randomized, double-blind crossover trial in 30 active drugs were given in deliberately small doses elderly patients suffering from moderate to severe as it is well recognized that age is highly correlated pain, the analgesic efficacy, tendency to produce with the pain relief obtained from a given dose of mental confusion and side effect profile of meptazinol analgesic (Beliville et al., 1971) and that the elderly 100 mg orally were compared with those of pentazo- are more susceptible to drugs in general (Leading cine 25 mg orally and placebo. Article, 1977). Both the active drugs produced significantly better analgesia than placebo but meptazinol also provided Materials and methods significantly better pain relief than pentazocine, This was a randomized double-blind crossover whilst at the same time causing less mental confusion. trial in 30 patients over the age of 70 years who had Side effects were unremarkable. given informed consent to participate and whocopyright. Meptazinol appears to be a better general purpose would in any case have required a potent oral anal- oral analgesic in this group of patients than penta- gesic. Eighteen patients were female, and the mean zocine. age was 81-4+6-4 years. Introduction TABLE 1. Painful conditions for which It is commonly found that when it is necessary to analgesia was required use a strong such as an opiate or penta- analgesic Fractured neck of femur zocine in an elderly person there is a high incidence Paget's disease http://pmj.bmj.com/ of adverse CNS effects such as confusion, agitation Intractable headaches of unknown origin or hallucinations and these are clearly detrimental Seronegative arthritis both to the patient and to the running of the ward. Rheumatoid arthritis Osteoporosis Meptazinol is a novel benzomorphan compound Osteomalacia with partial opiate-antagonist properties which has Bony secondaries been shown to be equivalent in analgesic potency Carcinoma of pancreas at a dose of 100 mg to pethidine 100 mg (Paymaster, Carcinoma of caecum Large pressure sores on September 30, 2021 by guest. Protected 1977; A. Hedges (personal communication); M. B. Dislocated acromioclavicular joint A. Jackson and P. J. Robson (personal com- Spondylosis munication), papaveretum 20 mg (Moyer, Miller Angina pectoris and Aldridge, 1979) and pentazocine 60 mg (Pay- Carcinoma of breast Multiple pyarthrosis master, 1977), all drugs given i.m. It is free from Carcinoma of prostate anti-5-hydroxytryptamine and anti-cholinergic acti- Fractured ankle vity and in clinical trial has shown a low incidence of CNS side effects. An additional factor in the group of patients is meptazinol's favourable On admission to the study, all analgesics and non- respiratory profile (Jordan et al., 1979). essential drugs were discontinued and each patient An open pilot study in 11 patients revealed that was randomly allocated to either Group A, Group B meptazinol 100 mg orally gave satisfactory pain or Group C. The painful conditions for which the relief and was well tolerated, so it was therefore patients required relief are shown in Table 1. Each decided to compare the compound for efficacy and patient then received in random order placebo, side effect incidence with the oral analgesic most meptazinol 100 mg and pentazocine 25 mg according frequently used for moderate to severe pain in the to the following routine. 0032-5473/80/0700-0474 $02.00 © 1980 The Fellowship of Postgraduate Medicine Postgrad Med J: first published as 10.1136/pgmj.56.657.474 on 1 July 1980. Downloaded from Treatment ofpain in the elderly 475 On admission to the trial, and when an analgesic pain of various aetiologies received 100 mg mepta- was requested by the patient, the pain intensity score zinol by mouth, and an 'E' test and pain intensity was measured using a visual analogue scale, and the scored by visual analogue scale were measured at mental state assessed by the 'E' test. In this test, the following time-points; 0, 30 min, 1, 2, 3, and the patient is given a typewritten passage of writing 4 hr. The mean results for the group are illustrated which contains 50 letter 'E's, and is asked to read graphically in Fig. 1. Whereas mean pain intensity through the piece crossing out the 'E's, thereby is significantly reduced from 30 min onwards obtaining a score out of 50. A different passage is (P<0-025-Wilcoxon matched pairs signed rank used for each assessment, and it is generally accepted test), the fluctuations in 'E' score do not reach statisti- that performance in this test correlates well with the cal significance. degree of mental confusion. Other observations made at this time included pulse rate, BP and the Double-blind study presence or absence of any other symptoms such as The pain intensity difference and 'E' scores are nausea and vomiting. Test drug no. 1 was then displayed graphically as group means in Figs 2 and 3. given, and the above observations repeated at 30 Pain intensity difference is obtained by subtracting min, one hr, 2 hr, and 4 hr. When next the patient the pain intensity at the various time-points from requested an analgesic, an identical procedure was the pre-treatment pain intensity for each individual. adopted for test drug 2 and likewise for test drug 3. Both meptazinol and pentazocine gave significant In the event of analgesia being inadequate during pain relief at all times over the 4-hr period in an observation period, the pain intensity for comparison with placebo, and meptazinol gave unmeasured time-points was adjudged as the significantly better pain relief than pentazocine at maximum, 10, and the next test drug was given one and 2 hr after dosing. At 3 and 4 hr, the pain according to the randomized schedule. Blood relief afforded by the 2 active agents did not signi- samples for the measurement of meptazinol con- ficantly differ. centration in plasma were taken at the observation Pentazocine depressed the 'E' score significantly time-points from some in the trial. more than the 4-hr patients meptazinol throughout period copyright. and indeed meptazinol differed from placebo in this regard at the 2-hr time-point only. Results None of the test drugs had any significant effect Open pilot study on BP or pulse rate, and the side effect profile is Eleven patients suffering from moderate to severe shown in Table 2. http://pmj.bmj.com/ ' 6 )^ 4 X (^**^ ** ) <" -X (**) (**) 2 (** ) on September 30, 2021 by guest. Protected xX~~~~ x 'E' Score '6 40 (NS) 20 0 2 3 4 Time (hrl FIG. 1. Results of open pilot study. Comparison with base line. (*) P, 0-025; (**) P, 0-005; (NS) not significant. Postgrad Med J: first published as 10.1136/pgmj.56.657.474 on 1 July 1980. Downloaded from 476 V. Pearce and P. J. Robson aL) 0 c cr Q) axS Time (hr) FIG. 2. Group mean pain intensity differences. x x metazinol 100 mg; ®g ®g pentazocine 25 mg; O 0 placebo. copyright. 35 (NS) X ~~~~~~~~~~~~~~~~~~~~~~~~~x a P<0-0 (NS) http://pmj.bmj.com/ 30 _ P<001 Li on September 30, 2021 by guest. Protected Time (hr) FIG. 3. Group mean 'e' scores. TABLE 2. Side effects Side effect Placebo Meptazinol Pentazocine Nausea and vomiting 0 2 0 Nausea alone 0 1 1 Dizziness 1 0 0 Postgrad Med J: first published as 10.1136/pgmj.56.657.474 on 1 July 1980. Downloaded from Treatment ofpain in the elderly 477 Peak plasma concentrations tended to occur at pentazocine for the entire period studied. No patient 2-3 hr after dosing, and the mean plasma con- was noticeably confused or obtunded at the doses centration at this time in a group of 12 patients was used. 20 1 17-3 (s.d.) ng/ml. In this group of very elderly patients in whom depression of awareness rapidly leads to deterioration Discussion of bladder control, diminution ofmobility to pressure Adverse reactions to drug therapy in the elderly necrosis of skin, and constipation to discomfort and are a major cause of morbidity. Important pre- eventual overflow incontinence of faeces, the disposing factors are age and sex; significantly more potential advantage of an effective analgesic agent patients aged 60 years and over, and more women attended by a diminished incidence of these prob- than men develop adverse reactions (Hurwitz, 1969). lems is self-evident. Neurological and mental disturbances due to drug therapy are extremely common in the elderly, who are particularly susceptible to centrally acting drugs. Conclusion The reactions seen include mental confusion, The present trial demonstrates that oral mepta- disorientation, hallucinations, fluctuating levels of zinol offers advantages over pentazocine in the awareness and depression (Davison, 1978). The routine treatment of moderate to severe pain in the elderly metabolize many drugs more slowly than do elderly. the young, and plasma half-lives for a given dose The relief of pain by meptazinol as judged by a are prolonged (O'Mally et al., 1971). visual analogue scale was significantly better than The chief factors involved seem to be a reduced that following pentazocine. lean body mass and a substantial pre-existing Awareness was significantly less impaired by impaired function of certain organs and systems, meptazinol than by pentazocine.
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