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NCT04551196 · ClinicalTrials.gov registry record · Phase 3
Management of Post-Tonsillectomy Pain in Pediatric Patients
A Phase 3 study of Pain, Postoperative and Tonsillitis, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04551196: Completed Phase 3 study of Pain, Postoperative and Tonsillitis, sponsored by Washington University School of Medicine.
NCT04551196 is a Phase 3 study of Pain, Postoperative and Tonsillitis that has completed, run by Washington University School of Medicine. The registered enrollment target is 50 participants, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04551196, a Phase 3 study of Pain, Postoperative and Tonsillitis, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Alternating Acetaminophen and Ibuprofen
- DRUG Combined Acetaminophen and Ibuprofen
Study Locations (1)
Missouri
- Saint Louis Children's Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2022-11-10 |
| Phase | Phase 3 |
What the finished NCT04551196 record still lists
NCT04551196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Alternating Acetaminophen and Ibuprofen is the first listed.
NCT04551196 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04551196 about?
NCT04551196 is a clinical study titled "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 rec...
What is the current status of trial NCT04551196?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2020-09-28. Estimated completion is 2022-11-10.
What conditions does trial NCT04551196 study?
This clinical trial studies the following conditions: Pain, Postoperative, Tonsillitis, Tonsillar Hypertrophy.
What interventions are being tested in trial NCT04551196?
The interventions under investigation include: Alternating Acetaminophen and Ibuprofen (DRUG), Combined Acetaminophen and Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT04551196?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04551196 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04551196's enrollment target sits among peer trials
50 90th of 113 higher than 20 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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