Overview

This trial is active, not recruiting.

Conditions parental/caregiver anxiety, child's anxiety
Treatments zolpidem, midazolam
Phase phase 3
Sponsor Loma Linda University
Start date June 2014
End date February 2017
Trial size 86 participants
Trial identifier NCT02096900, 5140032

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
zolpidem given orally 0.25mg/kg pre-operatively single dose
zolpidem ambien
Zolpidem will be given one time at 0.25 mg/kg pre-operatively
(Active Comparator)
midazolam will be given at 0.5mg/kg, pre-operatively single dose
midazolam versed

Primary Outcomes

Measure
Patient anxiety at the time of separation
time frame: Study participation will be about 1 day including the preoperative, perioperative at the time of induction, and postoperative period

Secondary Outcomes

Measure
Other comparison measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance characteristics at the time of induction, and time to full recovery in the post operative period.
time frame: Secondary outcome measures will begin when the parent/caregiver completes the STAI questionnaire prior to the study medication being given to the subject.

Eligibility Criteria

Male or female participants from 2 years up to 9 years old.

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.

Additional Information

Official title A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Principal investigator Amgad Hanna, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Loma Linda University.