A Comparison of Midazolam and Zolpidem as Oral Premedication in Children

NCT02096900 | Completed Phase 3 Results DMC

• 1 other identifier: 5140032
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

Pre-medication; Pre-operative anxiety

Outcome Measures

Primary Outcomes (1)

• Patient Anxiety at the Time of Separation

  The primary outcome measure of patient anxiety will be measured using the validated Modified Yale Preoperative Anxiety Score (mYPAS). The mYPAS is the current standard for evaluation of anxiety in children receiving anesthesia for surgical procedures. The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children. It was developed by the study group lead by Kain Z. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious.

  Up to 24 hours including preoperative, preoperative, and postoperative periods.

Secondary Outcomes (3)

• Mask Acceptance Score

  During induction of general anesthesia.

• Presence of Emergence Delirium During Recovery

  Up to 30 minutes after child's first eye opening in the post-operative period.

• Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)

  Preoperative holding area from the time of informed consent until caregiver/patient separation.

Study Arms (2)

zolpidem

ACTIVE COMPARATOR

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

Drug: zolpidem

midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam

Interventions

zolpidem DRUG

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

Also known as: ambien

zolpidem

Midazolam DRUG

Also known as: versed

midazolam

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Zolpidem; Midazolam

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Amgad H. Hanna, MD
• Organization: Loma Linda University

ahanna@llu.edu

909-558-4475

Study Officials

• Amgad Hanna, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: July 21, 2014
• Primary Completion: May 6, 2016
• Study Completion: May 6, 2016
• Last Updated: March 14, 2019
• Results First Posted: August 11, 2017

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)