Management of Post-Tonsillectomy Pain in Pediatric Patients

January 26, 2023 updated by: Washington University School of Medicine

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alternating Regimen
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Drug: Alternating Acetaminophen and Ibuprofen
Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
Other Names:
  • Alternating regimen
Active Comparator: Combined Regimen
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Drug: Combined Acetaminophen and Ibuprofen
Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
Other Names:
  • Combined regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of FLACC pain scores ≥7 from POD 1 through POD 3
Time Frame: 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.
up to 3 days following consent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of FLACC pain scores ≥7 on each individual POD 1, 3, and 7
Time Frame: 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.
3 separate individual days, will be completed days after the surgery
Proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7
Time Frame: 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.
up to 7 days following consent
Proportion of Faces pain scores ≥8 on POD 1, 3, and 7
Time Frame: 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.
3 separate individual days, will be completed days after the surgery
Proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7
Time Frame: 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.
up to 7 days following consent
Rescue Medication Usage through POD 3
Time Frame: 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.
up to 3 days following consent
Rescue Medication Usage through POD 7
Time Frame: 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.
up to 7 days following consent
Proportion of subjects that adhere to the assigned medication regimen
Time Frame: 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.
up to 3 days following consent
Adverse Events
Time Frame: up to 7 days following consent
Incidence of adverse events
up to 7 days following consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2020

Primary Completion (Actual)

November 10, 2022

Study Completion (Actual)

November 10, 2022

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202002118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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