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NCT01777854 · ClinicalTrials.gov registry record · Phase 4
Anti-reflux Control to Decrease Post Tonsillectomy Pain
A Phase 4 study, sponsored by Ascension Health.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT01777854 is a Phase 4 study that was terminated before completion, run by Ascension Health. The registered enrollment target is 6 participants.
The verdict
NCT01777854, a Phase 4 study, was terminated before completion, sponsored by Ascension Health.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study Summary
The study aims to determine if treating pediatric patients (age 7-17) for four weeks with omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance into the oropharynx, patients will have less post tonsillectomy pain due to decreased acid irritation of the surgical wound (tonsil fossas). The study will be a prospective double blind randomized study. Participants will be invited to participate in the study by giving the study information at the preoperative assessment, when the decision is made to have a tonsillectomy performed. If the patient agrees to participate in the study, a written consent and child assent will be obtained and the patient will be randomly assigned to a treatment versus control group based on the randomly assigned participant number. The treatment group will then be given a four week course of omeprazole to be taken for the four weeks prior to tonsillectomy. The patient will be given a post tonsillectomy assessment form. The form looks at postoperative pain (using a visual analog scale 1-10) as well as oral intake at postoperative day 0,1,3,5,7,10, and 14. The form will be turned in at the postoperative visit or mailed in. The pain level and oral intake between the two groups to will be compared to determine if antireflux control helps decrease the postoperative pain after tonsillectomy.
Interventions
- DRUG Omeprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01777854
The ClinicalTrials.gov registry entry for NCT01777854 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascension Health, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omeprazole is the first listed.
NCT01777854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01777854 about?
NCT01777854 is a clinical study titled "Anti-reflux Control to Decrease Post Tonsillectomy Pain". The study aims to determine if treating pediatric patients (age 7-17) for four weeks with omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance into the oropharynx, patients...
What is the current status of trial NCT01777854?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2013-01. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01777854?
The interventions under investigation include: Omeprazole (DRUG).
Who is sponsoring clinical trial NCT01777854?
This trial is sponsored by Ascension Health, which has 10 total clinical trials registered on ClinicalTrials.gov.
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