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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 is a Phase 4 study that was terminated before completion, run by Emory University. The registered enrollment target is 45 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02296840
The ClinicalTrials.gov registry entry for NCT02296840 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ibuprofen is the first listed.
NCT02296840 reports 0 study locations.
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.
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