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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: Completed Phase 3 study, sponsored by Loma Linda University.
NCT02096900 is a Phase 3 study that has completed, run by Loma Linda University. The registered enrollment target is 86 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure of patient anxiety will be measured using the validated Modified Yale Preoperative Anxiety Score (mYPAS). The mYPAS is the current standard for evaluation of anxiety in children receiving anesthesia for surgical procedures. The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children. It was developed by the study group lead by Kain Z. It consists of assessment of 27 items in 5 domains of behavior ind
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 |
What the finished NCT02096900 record still lists
NCT02096900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT02096900 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02096900's enrollment target sits among peer trials
86 1745th of 2000 higher than 254 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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