Management of Post-Tonsillectomy Pain in Pediatric Patients

Phase 3

Completed

• Conditions: Pain, Postoperative; Tonsillar Hypertrophy; Tonsillitis
• Interventions: Drug: Combined Acetaminophen and Ibuprofen; Drug: Alternating Acetaminophen and Ibuprofen

• Registration Number: NCT04551196
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-16
• Study Start: 2020-09-28
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Results First Submitted: 2023-11-27
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Results First Posted: 2024-07-11
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Regimen	Combined Acetaminophen and Ibuprofen	A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Alternating Regimen	Alternating Acetaminophen and Ibuprofen	A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.

Primary Outcome Measures

Name	Time	Method
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3	up to 3 days following consent	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Rescue Medication Usage Through POD 3	up to 3 days following consent	The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.
Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7	3 separate individual days, will be completed days after the surgery	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.
Adverse Events	up to 7 days following consent	Incidence of adverse events
Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7	3 separate individual days, will be completed days after the surgery	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.
Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7	up to 7 days following consent	The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 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.
Number of Participants With Rescue Medication Usage Through POD 7	up to 7 days following consent	The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.
Proportion of Subjects That Adhere to the Assigned Medication Regimen	up to 3 days following consent	Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study.
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7	up to 7 days following consent	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.

Trial Locations

Locations (1)

Saint Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States