Management of Post-Tonsillectomy Pain in Pediatric Patients

Washington University School of Medicine50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain, Postoperative Tonsillar Hypertrophy Tonsillitis

Interventions

Alternating Acetaminophen and IbuprofenDRUG

Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.

Combined Acetaminophen and IbuprofenDRUG

Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Saint Louis Children's Hospital

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3

The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.

Time frame: up to 3 days following consent

Secondary Outcomes

Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7

The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.

Time frame: 3 separate individual days, will be completed days after the surgery

Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7

The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.

Time frame: up to 7 days following consent

Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7

The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.