NCT04551196

Management of Post-Tonsillectomy Pain in Pediatric Patients

Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.

Conditions

• Pain, Postoperative
• Tonsillar Hypertrophy
• Tonsillitis

Interventions

Type	Name	Description
DRUG	Alternating Acetaminophen and Ibuprofen	Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
DRUG	Combined Acetaminophen and Ibuprofen	Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.

Timeline

• Start date: 2020-09-28
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2020-09-16
• Last updated: 2024-07-11
• Results posted: 2024-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study