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Management of Post-Tonsillectomy Pain in Pediatric Patients

NCT04551196 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-07-11

Study results available
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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

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2022-11-10
Completion
2022-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04551196 on ClinicalTrials.gov