Comparison of dexmedetomidine versus midazolam for intranasal premedication in children posted for elective surgery: a double-blind, randomised study

Abstract

Objective: The aim of this study was to compare the effect of dexmedetomidine with midazolam for intranasal premedication in children posted for elective surgery. Trial design: This was a prospective, randomised, double-blinded clinical study. Method: 60 children, 3 to 10 years of age, with American Society of Anaesthesiologists (ASA) physical status I, scheduled for elective surgery, were randomly divided into two groups, group D (dexmedetomidine) and group M (midazolam). Group D patients received intranasal dexmedetomidine 1 μg/kg and group M patients intranasal midazolam 0.2 mg/kg, approximately 30 minutes before induction of anaesthesia, in the form of a spray. Outcome: Preoperative effects on heart rate, blood pressure, sedation and anxiety including parental separation and mask acceptance were assessed. Results: Intranasal dexmedetomidine (1 μg/kg) premedication resulted in statistically significant but clinically unimportant lower heart rate and blood pressure at 10, 20, and 30 minutes following administration compared with intranasal midazolam (0.2 mg/kg). There were no episodes of hypotension or bradycardia. Children in group D achieved better parental separation and mask acceptance scores compared with group M. Conclusion: Dexmedetomidine resulted in better parental separation and mask acceptance scores than intranasal midazolam. Thus it would seem to offer some advantage compared with midazolam.

The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis

“…The included articles were undertaken from 2008-2016 in eight different countries: USA (one), Turkey (one), Saudi Arabia (one), India (three), China (three), Egypt (two), Mexico (one), and Oman (one). Four studies 13,18,19,22 compared the effects of intranasal dexmedetomidine with those of oral midazolam, and six studies 10,11,14,16,17,21 compared the effects of intranasal dexmedetomidine with those of intranasal midazolam. One study compared intranasal dexmedetomidine with intranasal clonidine, 15 and two studies compared intranasal dexmedetomidine with intranasal normal saline.…”

“…All of the included studies used a random allocation method. Ten studies [10][11][12][13][14][15][16][17][18]22 described the allocation concealment in detail, and six studies 10,11,13,15,16,22 concretely explained their blinding methods. The risk of allocation concealment and blinding was unclear in the other studies.…”

Randomized Double Blind Clinical Trial of Intramuscular Dexmedetomidine v/S Midazolam as Premedication in Paediatric Surgical Patients

“…21 and Pasin L. compared dexmedetomidine with midazolam as a premedication in their meta-analysis; their results concluded that dexmedetomidine premedication resulted in a better sedative and anxiolytic effect during parent separation. In a study by Singlaa D. 15 , a double-blind, randomised study to compare dexmedetomidine versus midazolam for intranasal premedication in children posted for elective surgery. Dexmedetomidine resulted in better mask acceptance score than intranasal midazolam; similar results were seen in a study conducted by Seyedeh Z to compare oral Dexmedetomidine versus Midazolam as Anaesthetic Premedication in Children.…”

“…13,14 Anxiety during separation was evaluated by parent separation anxiety score. 14,15 Mask acceptance was evaluated by mask acceptance score. 14,15,16 While wake up behaviour was evaluated by wake up score.…”

“…14,15 Mask acceptance was evaluated by mask acceptance score. 14,15,16 While wake up behaviour was evaluated by wake up score. 14,17 , postoperative pain was evaluated by Face pain scale revised.…”