Management of Post-Tonsillectomy Pain in Pediatric Patients

The Washington University

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative; Tonsillitis; Tonsillar Hypertrophy

Treatments: Drug: Alternating Acetaminophen and Ibuprofen; Drug: Combined Acetaminophen and Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT04551196

202002118

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 4 to 17 years of age at time of enrollment
• Undergoing tonsillectomy with or without adenoidectomy
• Able to provide informed consent from parent or legal guardian
• Able to provide assent if subject is a minor of appropriate age

Exclusion criteria

• Allergy to acetaminophen or ibuprofen
• Inability for study participant to cooperate with pain assessments
• Known pregnancy
• Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Alternating Regimen

Active Comparator group

Description:

A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.

Treatment:

Drug: Alternating Acetaminophen and Ibuprofen

Combined Regimen

Active Comparator group

Description:

A regimen of acetaminophen and ibuprofen dosed together every 6 hours.

Treatment:

Drug: Combined Acetaminophen and Ibuprofen