Clinical trial NCT04551196: Management of Post-Tonsillectomy Pain in Pediatric Patients
Official title: Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Tonsillar Hypertrophy
Tonsillitis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, randomized, open-label, non-inferiority treatment pilot study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3
timeFrame: up to 3 days following consent
Secondary outcomes:
measure: Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7
timeFrame: 3 separate individual days, will be completed days after the surgery
measure: Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7
timeFrame: up to 7 days following consent
measure: Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7
timeFrame: 3 separate individual days, will be completed days after the surgery
measure: Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7
timeFrame: up to 7 days following consent
measure: Number of Participants With Rescue Medication Usage Through POD 3
timeFrame: up to 3 days following consent
measure: Number of Participants With Rescue Medication Usage Through POD 7
timeFrame: up to 7 days following consent
measure: Proportion of Subjects That Adhere to the Assigned Medication Regimen
timeFrame: up to 3 days following consent
measure: Adverse Events
timeFrame: up to 7 days following consent
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis Children's Hospital
state: Missouri
Study officials:
References:
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