Midazolam-Dexmedetomidine Combination versus Midazolam Alone for Premedication in Children Undergoing Pediatric Cataract Surgeries: a Double-Blinded Randomized Controlled Trial

Background:Dexmedetomidine, a selective ??2 agonist has shown promising results when used as a premedicant. This prospective randomized study evaluated the efficacy of two different premedication regimens in achieving a smooth conduct of anesthesia and optimum pain relief in pediatric cataract surgeries. Methods:90 ASA I or II children, aged 1-6 years, scheduled for elective cataract surgeries were randomized to receive either 0.25 mg kg-1oral midazolam and 1 mu g kg-1 of intranasal dexmedetomidine (Group MD; n=45) or 0.5mg/kg oral midazolam followed by 0.02ml kg-1 intranasal saline drops (Group MS; n=45) 45 min prior to surgery. Drug acceptance, anxiety at parental separation and quality of mask induction was evaluated. Subtenon block was given to all the children. Intraoperative use of narcotics was avoided and used only as rescue drug. Primary outcome of the study was number of patients requiring rescue analgesia over 24-hour period. The secondary outcomes were time to first rescue analgesia, frequency of rescue analgesia, incidence of OCR and PONV.Results:90% of the children in Group MD achieved MOAA/S <= 4 at 30 minutes versus 95% in Group MS. Drug acceptability, parental separation and mask acceptance were similar in both groups. Incidence of PONV and children who required rescue analgesia was less in MD group compared with MS group. There was no event of OCR in both groups. Conclusion: Premedication with combined IND and low dose oral midazolam is superior in decreasing postoperative analgesic requirements when compared to routine oral midazolam premedication alone in pediatric cataract surgeries under general anesthesia.