Does Montelukast Decrease Post‐Adenotonsillectomy Pain in Children? A Randomized Controlled Trial

ABSTRACT Objective To evaluate the effectiveness of perioperative Montelukast as an analgesic for adenotonsillectomy. Methods This was a randomized controlled double‐blind trial. The trial enrolled 116 children between the age of 3–8 undergoing adenotonsillectomy with planned 23‐h observation for sleep disordered breathing were randomized to receive either montelukast or placebo perioperatively. Outcome variables including postoperative opioid usage, FLACC pain scores, post‐tonsillectomy hemorrhage rate (PTH), and number of postoperative contacts were examined. Results One‐hundred and thirteen patients received either montelukast or placebo, and 92 received a second dose of the same. There were no differences in demographics between groups. There were no significant differences in the proportion of patients requiring opioids in PACU (46% in control group vs. 45% in the montelukast group, p = 0.9) or the number of postoperative contacts between groups. There was no difference in PTH between groups ( p < 0.01). Conclusion Montelukast does not lead to lower rates of pain postoperatively compared to placebo in patients undergoing adenotonsillectomy for sleep disordered breathing and does not lower postoperative contacts with the medical system. Trial Registration ClinicalTrials.gov identifier: NCT02793375 Level of Evidence 2