Surgery Clinical Trial - Opioid-Free Anesthetic for Tonsillectomy

Status Recruiting

Clinical Trial Summary

Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic

Clinical Trial Description

Objectives: Primary: To determine if an opioid-free anesthetic provides equivalent acute postoperative pain relief in tonsillectomy. Secondary: To determine if post-operative pain at home is not significantly different with an opioid-free regimen compared to an opioid containing regimen for tonsillectomy. Study Design: Prospective, randomized, multi-center trial study Study Interventions and Measures: Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group The primary endpoint is the median pain score (calculated by a blinded validated observer in the recovery room at two time intervals) between the two cohorts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04528173
Study type	Interventional
Source	Children's Hospital of Philadelphia
Contact	Tori N Sutherland, MD,MPH
Phone	267-426-2961
Email	sutherlant@chop.edu
Status	Recruiting
Phase	Phase 4
Start date	July 22, 2020
Completion date	December 31, 2023

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