Phase 3
N=86
A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Parental/Caregiver Anxiety · Child's Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02096900 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Patient Anxiety at the Time of Separation — 26.69; 30.00 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- zolpidem (Drug); Midazolam (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Anxiety at the Time of Separation |
26.69; 30.00 | — |
| SECONDARY Mask Acceptance Score |
34; 29; 4; 13 | — |
| SECONDARY Presence of Emergence Delirium During Recovery |
26; 32; 12; 10 | — |
| SECONDARY Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI) |
41.74; 41.12; 31.81; 34.12; 44.33; 43.85 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Pediatric patients ages 2-9 years
- ASA class I-II
- inpatient surgeries of at least 2 hours duration
- requiring postoperative admission of at least 23 hours Exclusion Criteria:
Exclusion Criteria
- contraindication to preoperative sedation, known allergy or sensitivity to the study medications,
- those who lack legal representative consent
- Patients with weights lying below the 5th percentile or above the 95th percentile according to the current published CDC growth chart will also be excluded regardless of existing specific contraindication.
Data sourced from ClinicalTrials.gov (NCT02096900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.