NCT02096900

A Comparison of Midazolam and Zolpidem as Oral Premedication in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parental/Caregiver Anxiety
• Child's Anxiety

Interventions

Type	Name	Description
DRUG	zolpidem	Zolpidem will be given one time at 0.25 mg/kg pre-operatively
DRUG	Midazolam

Timeline

• Start date: 2014-07-21
• Primary completion: 2016-05-06
• Completion: 2016-05-06
• First posted: 2014-03-26
• Last updated: 2019-03-14
• Results posted: 2017-08-11

Locations

1 site across 1 country: United States