Phase 3
Completed N=50
Management of Post-Tonsillectomy Pain in Pediatric Patients
Pain, Postoperative · Tonsillar Hypertrophy · tonsillitis
Source: ClinicalTrials.gov NCT04551196 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3 — 1; 1 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3 |
1; 1 | — |
| SECONDARY Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7 |
1; 1 | — |
| SECONDARY Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7 |
1; 1 | — |
| SECONDARY Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7 |
1; 1 | — |
| SECONDARY Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7 |
3; 1 | — |
| SECONDARY Number of Participants With Rescue Medication Usage Through POD 3 |
3; 7 | — |
| SECONDARY Number of Participants With Rescue Medication Usage Through POD 7 |
1; 0 | — |
| SECONDARY Proportion of Subjects That Adhere to the Assigned Medication Regimen |
25; 25 | — |
| SECONDARY Adverse Events |
3; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT04551196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.