Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02296840 · ClinicalTrials.gov registry record · Phase 4
Post-operative Pain Control After Pediatric Adenotonsillectomy
A Phase 4 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT02296840: Clinical Trial Phase 4 study, sponsored by Emory University.
NCT02296840 is a Phase 4 study that was terminated before completion, run by Emory University. The registered enrollment target is 45 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02296840, a Phase 4 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric population in the United States. It is generally a well-tolerated procedure with post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or re-admission to the hospital. Post-operative analgesia is most commonly managed with narcotic-containing pain medication. In recent years however, there is evidence that some patients may manifest increased sensitivity to narcotics, resulting in life-threatening respiratory compromise. Though there is a theoretical risk that nonsteroidal anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation, evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains inconclusive for these generally well-tolerated medications. The goal of this study is to determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs in the management of post-operative pain following pediatric adenotonsillectomy, versus more commonly used narcotic pain medication. The study design will be an initial retrospective study to collect pilot data on the incidence of postoperative hemorrhage and indicators of adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This will be followed by a prospective, randomized, single-blind controlled study in which orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone (control intervention) in the postoperative period following adenotonsillectomy.
Primary Outcome
Using the Faces Pain Scale, the pediatric patient will indicate his/her pain level at scheduled intervals (7 times per day) for 14 days post-surgery.The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. For this analysis, participant pain scores were summed and the mean per group was calculated. Total summed scores coul
Interventions
- DRUG Ibuprofen
- DRUG Hydrocodone-Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-11-30 |
| Phase | Phase 4 |
Why NCT02296840 stopped before completion
NCT02296840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibuprofen is the first listed.
NCT02296840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02296840 about?
NCT02296840 is a clinical study titled "Post-operative Pain Control After Pediatric Adenotonsillectomy". Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric population in the United States. It is generally a well-tolerated procedure with post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following adenotonsillectomy has significant mo...
What is the current status of trial NCT02296840?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2014-11. Estimated completion is 2016-11-30.
What interventions are being tested in trial NCT02296840?
The interventions under investigation include: Ibuprofen (DRUG), Hydrocodone-Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT02296840?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02296840's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia