A Comparison of Midazolam and Zolpidem as Oral Premedication in Children

NCT ID: NCT02096900

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-21
• Study Completion Date: 2016-05-06

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

zolpidem

zolpidem given orally 0.25mg/kg pre-operatively single dose

Group Type: ACTIVE_COMPARATOR

zolpidem

Intervention Type: DRUG

Zolpidem will be given one time at 0.25 mg/kg pre-operatively

midazolam

midazolam will be given at 0.5mg/kg, pre-operatively single dose

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

Interventions

zolpidem

Zolpidem will be given one time at 0.25 mg/kg pre-operatively

Intervention Type: DRUG

Midazolam

Intervention Type: DRUG

Other Intervention Names

ambien; versed

Eligibility Criteria

Inclusion Criteria

• Pediatric patients ages 2-9 years
• ASA class I-II
• inpatient surgeries of at least 2 hours duration

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Davinder Ramsingh, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amgad Hanna, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

Other Identifiers

5140032

Identifier Type: -

Identifier Source: org_study_id