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Premedicant in Childr Vs. Triclofos Dicant in Children: Efficacy of Oral Midazolam Acy of Oral Midazolam

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Premedicant in Childr Vs. Triclofos Dicant in Children: Efficacy of Oral Midazolam Acy of Oral Midazolam Research Article Premedicant in childr en: efficacy of oral Midazolam Vs. Triclofos Maya Rose Jose 1* , Sanjana Vinod 2 1Assistant Professor, 2Consultant Department of Anaesthesiology, Academy of Medical Sciences, Pariyaram, Kannur, Kerala – 670503 INDIA. Email: [email protected] Abstract Hospital admission, anesthesia and surgery are stressful experiences for children which may lead to psychological trauma and personality changes. The increasing use of day care surgery, the avoidance of parental separation and the use of sedative premedica tion may reduce the stress of hospitalization in children and the risk of adverse psychological sequel. Search for an ideal premedicant drug for children is still on. Aims and objectives: To compare and evaluate the efficacy of midazolam and triclofos when given orally as premedicants in children. Materials and methods: In the present study 50 children were selected and were divided in two groups (midazolam group and triclofos group). Preoperative assessment was performed one day before the surgery by an ob server. Evaluation of post-premedication sedation (thirty minutes post-premedication in the Midazolam group and sixty minutes post -premedication in the Triclofos group) was recorded. Level of sedation at the post premedication and level of sedation at the time of separation from parents was recorded. Behavior at the time of separation from parents and behavior during mask acceptance was recorded and analyzed. Results: On Post Premedicant it was observed that in midazolam group majority children (22) had se dation score of two whereas in triclofos group majority of the children (21) had sedation score four . Evaluation of the level of sedation at the time of separation from parents showed that majority of the children (22) in the Midazolam group had a sedation score of two whereas in triclofos group majority of the children (20) were having score four. The comparison of sedation scores between the two groups was done using the Fisher’s exact probability test. The difference between the two groups was very highl y significant statistically. While studying behavior at the time of separation from parents, it was observed that majority of the children in midazolam and triclofos were having score four (21 and 23 children respectively). In the Midazolam group, 14 child ren had a mask acceptance score of four and in the triclofos group, 20 children had a mask acceptance score of four. Conclusion: Even though the children are less sedated with oral midazolam as compared to triclofos, if produces an equally satisfactory sep aration from parents and satisfactory mask acceptance. Key Word: oral Midazolam, Triclofos. Address for Correspondence Dr. Maya Rose Jose, B.II quarters, S4 . Pariyaram Medical College Campus , Pariyaram, Kannur, Kerala – 670503 INDIA. Email: [email protected] Received Date: 11/01/2015 Revised Date: 16/01/2015 Accepted Date: 21/01/2015 increasing use of day case surgery, the avoidance of Access this article online parental separation and the use of sedative premedica tion may reduce the stress of hospitalization in children and Quick Response Code: Website: the risk of adverse psychological sequel. The ideal www.statperson.com premedicant in children should be readily acceptable, have rapid and reliable onset with minimal side effects that would necessitate high levels of nursing supervision, provide for a rapid recovery and return to alertness DOI: 22 January 2015 postoperatively, thereby permitting early discharge from recovery area. Recent reports suggest that oral midazolam may fulfill many of these criteria. 1,2,3,4. Moreover various routes of administration have been used in children for INTRODUCTION preanesthetic sedation; the oral route remains the least Hospital admission, anesthesia and surgery are threatening method of drug administration. Midazolam is stressful experiences for children which may lead to a potent imidazobenzodiazepine which possesses typical psychological trauma and personality changes. The benzodiazepine properties na mely, hypnotic and How to site this article: Maya Rose Jose, Sanjana Vinod . Premedicant in children: e fficacy of oral Midazolam V s. Triclofos. International Journal of Recent Trends in Science a nd Technology January 2015; 13(3): 625-629 http://www.statperson.com (accessed 24 January 2015). International Journal of Recent Trends in Science And Technology, ISSN 2277-2812 E-ISSN 2249-8109, Volume 13, Issue 3, 2015 pp 625-629 anxiolytic activity. Its short half life suggests that it • Coming for neurosurgical procedures should not prolong waking times. Midazolam has the • Children with mental retardation advantage of a rapid onset and relatively short duration of • Risk of pulmonary aspiration. action. Though the oral preparation of midazolam is commercially available now, the parental preparation is After the institutional Medical Ethics Committee still being used by the oral route after mixing it in a approval and by using the above mentioned inclusion and 5,6 vehicle to make it more palatable. Moreover, the IV exclusion criteria total 50 children were selected. An formulation by the oral route has been found to be more informed written consent was obtained from the parents reliable and effective as compared to the commercially of all the children. 6 available oral formulation. A dose of 0.25-0.5 mg/kg of Patients were randomly allocated into two midazolam orally has proven to be efficacious in children groups. 7 with fewer side-effects. Triclofos is a monosodium salt 1. Group M- Midazolam group of the phosphate ester Trichlorethanol (2,2,2- 2. Group T- Triclofos group Trichloroethanol dihydrogen phosphate). Triclofos is Midazolam (0.5 mg. kg -1) preparation was made by rapidly absorbed from the GIT. Triclofos sodium is mixing preservative free midazolam (1 ml=5mg) in rapidly hydrolysed to trichloroethanol. Trichloroethanol simple syrup base with orange flavor such that 1 ml=1 is the active metabolite and passes into the cerebrospinal mg. fluid, into breast milk, and across the placenta. The half- life of trichloroethanol in plasma is reported to range Preoperative assessment was performed one day from about 4 to 12 hours but is considerably prolonged in before the surgery by an observer. The observer was an the neonate. Tricloroethanol is excreted in the urine partly anesthesiology resident having at least two years as glucuronide conjugate (urochloralic acid) and as experience and was blinded to drug administered. Nil per 8 trichloroacetic acid. Triclofos has been used as a sedative orders were according to the protocol of the department. for short procedures, but has not been widely studied as a Evaluation of post-premedication sedation (thirty minutes premedicant. The oral solution is well-absorbed, proves post-premedication in the Midazolam group and sixty effective within 30-40 min and produces hypnosis for 6-8 minutes post-premedication in the Triclofos group) was 9 h in doses of 25-75 mg/kg. Thus the present study was recorded. undertaken to study to compare and evaluate the effects The following parameter was assessed to find the of midazolam and triclofos when given orally as efficacy of premedication premedicants in children. 1. Level of sedation post premedication (after an hour in the midazolam group and after half hour AIMS AND OBJECTIVES in the triclofos group). To compare and evaluate the efficacy of 2. Level of sedation at the time of separation from midazolam and triclofos when given orally as parents. premedicants in children. 3. Behavior at the time of separation from parents. 4. Behavior during mask acceptance MATERIALS AND METHODS 5. The time from premedication to separation The present double blinded randomized control The assessment was made by an observer who was trial was conducted with objective to study the efficacy of blinded to the premedication the child received. Rescue oral midazolam against triclofos. Following inclusion and medication was ketamine 3 mg.kg -1 with glycopyrrolate exclusion criteria was used to select the study subjects. (10ug.kg -1) if the separation was unsatisfactory (i.e. 1 or Inclusion criteria 2). • Children belonging to ASA physical status I or II • Age: 1-8 years The below table describes the various score used in the • Either gender present study. • Scheduled for elective surgery Score Criteria 1 Agitated • Maximum body weight up to 20 kg 2 Awake Sedation score Exclusion criteria 3 Drowsy • Children on anticonvulsant therapy and other 4 Asleep sedative medications 1 Poor (crying, clinging) Behavior at the 2 Fair (crying, not clinging) • Those likely to have anticipated difficult airway time of separation 3 Good (whimpers, easily reassured) • Known sensitivity to benzodiazepines from parents 4 Excellent (easy separation) International Journal of Recent Trends in Science And Technology, ISSN 2277-2812 E-ISSN 2249-8109, Volume 13, Issue 3, 2015 Page 626 Maya Rose Jose, Sanjana Vinod 1 Poor(terrified, crying) At the time 1 0 0 Behavior during 2 Fair (fear of mask, not reassured) of 2 22 4 mask acceptance <0.001 3 Good(slight fears of mask, reassured) separation 3 3 1 Significant 4 Excellent (unafraid, accept face mask) from 4 0 20 parents STATISTICAL ANALYSIS The result were analyzed using the unpaired t 22 test, Fisher‘s exact probability test. For the purpose of 25 21 statistical analysis, sedation score of 1 or 2 were clubbed 20 together as awake and scores 3 or 4 were clubbed 15 M (n=25) together as sedated and then analyzed. Because it was 10 4 3 T (n=25) considered that children with score 1 or 2 to be awake and 5 0 0 0 0 children who were drowsy and asleep to be sedated. Mask 0 acceptance score of 1 or 2 were clubbed together as 1 2 3 4 unsatisfactory and decided to compare with score of 3 or 4 clubbed as satisfactory and decided to compare with Figure 1: Post Premedicant Level of sedation score of 3 or 4 clubbed as satisfactory. On Post Premedicant it was observed that in RESULTS midazolam group majority children (22) had sedation score of two whereas in triclofos group majority of the Table 1: Demographic distribution of study subjects children (21) had sedation score four.
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