A Comparison of Midazolam and Zolpidem as Oral Premedication in Children

Last updated: March 12, 2019
Sponsor: Loma Linda University
Overall Status: Completed

Phase

3

Condition

Panic Disorders

Anxiety Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT02096900
5140032
  • Ages 2-9
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pediatric patients ages 2-9 years

  • ASA class I-II

  • inpatient surgeries of at least 2 hours duration

Exclusion

  • requiring postoperative admission of at least 23 hours Exclusion Criteria: Exclusion Criteria:

  • contraindication to preoperative sedation, known allergy or sensitivity to the studymedications,

  • those who lack legal representative consent

  • Patients with weights lying below the 5th percentile or above the 95th percentileaccording to the current published CDC growth chart will also be excluded regardlessof existing specific contraindication.

Study Design

Total Participants: 86
Study Start date:
July 21, 2014
Estimated Completion Date:
May 06, 2016

Connect with a study center

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Site Not Available

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