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NCT02096900 · ClinicalTrials.gov registry record · Phase 3
A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
A Phase 3 study, sponsored by Loma Linda University.
- Completed
- Registry status
- Phase 3
- Development phase
- 86
- Enrollment target
NCT02096900 is a Phase 3 study that has completed, run by Loma Linda University. The registered enrollment target is 86 participants.
The verdict
NCT02096900, a Phase 3 study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 86 participants
- Enrollment target
Study Summary
The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. No placebo will be administered in this study. Subjects will be male and female children between 2 and 9 years of age. In total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. A member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. Consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. Participants will be of ASA (American Society of Anesthesiologists) class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.
Interventions
- DRUG Midazolam
- DRUG zolpidem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2014-07-21 |
| Est. Completion | 2016-05-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02096900
The ClinicalTrials.gov registry entry for NCT02096900 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT02096900 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02096900 about?
NCT02096900 is a clinical study titled "A Comparison of Midazolam and Zolpidem as Oral Premedication in Children". The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral...
What is the current status of trial NCT02096900?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2014-07-21. Estimated completion is 2016-05-06.
What interventions are being tested in trial NCT02096900?
The interventions under investigation include: Midazolam (DRUG), zolpidem (DRUG).
Who is sponsoring clinical trial NCT02096900?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
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