Evaluation of the Analgesic Efficacy of Preemptive Dipyrone in the Postoperative Period of Adenotonsillectomy in Children: A Randomized Clinical Trial.

INTRODUCTION

Dipyrone is one of the most commonly used postoperative analgesics. However, there are only two randomized, placebo-controlled clinical trials evaluating its effect in pediatric tonsillectomies.

OBJECTIVE

To compare postoperative pain outcomes following the use of pre-incisional dipyrone or placebo in pediatric adenotonsillectomy.

METHODS

This was a randomized, double-blind, parallel, placebo-controlled clinical trial in children aged 4 to 14 years who underwent adenotonsillectomy. A total of 76 participants were randomized into the intervention/dipyrone group (n = 39) and the placebo group (n = 37). All received either dipyrone or saline solution (placebo) at one of two time points: before the surgical incision or at the end of surgery.

RESULTS

The mean age was 6.8 years and weight was 32.1 kg. In the intervention group, vital signs were normal and only 7.7% experienced emesis, compared with 8.1% in the placebo group. Food intake was anticipated by 1,1 hours in the dipyrone group. Pain was controlled in at least 77.6% of participants at all evaluated time points (H0, H1, H3, and H6) in both groups. At H3, pain was controlled in 54.2% of the intervention group compared with 45.8% in the placebo group. In addition, the dipyrone group demonstrated a tendency toward a lower need for opioids in H1 and H3, reducing opioid administration by 50% and 52.63%, respectively, compared with placebo.

CONCLUSION

A trend toward pain relief, earlier diet acceptance, and a lower need for opioids was observed in the group that received preemptive dipyrone. The results did not reach statistical significance, likely due to a type II error.