A Comparison of Midazolam and Zolpidem as Oral Premedication in Children (PedsPreMed)

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.

Study Overview

• Status: Completed
• Conditions: Parental/Caregiver Anxiety; Child's Anxiety
• Intervention / Treatment: Drug: Midazolam; Drug: zolpidem

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: zolpidem; zolpidem given orally 0.25mg/kg pre-operatively single dose	Drug: zolpidem; Zolpidem will be given one time at 0.25 mg/kg pre-operatively; Other Names: ambien
Active Comparator: midazolam; midazolam will be given at 0.5mg/kg, pre-operatively single dose	Drug: Midazolam; Other Names: versed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mask Acceptance Score	Mask acceptance by the patient, will be measured on a 4-point scale adapted from a similar trial. Score of 1 and 2 indicates satisfactory mask acceptance. Score of 3 or 4 indicates unsatisfactory mask acceptance during induction of general anesthesia.	During induction of general anesthesia.
Presence of Emergence Delirium During Recovery	Presence or absence of emergence delirium during recovery, will be assessed using the pediatric anesthesia emergence delirium (PAED) scale recorded at 5-minute intervals for 20 minutes following the child's spontaneous eye opening. PAED score of ≥12 at any time indicates presence of emergence delirium.	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)	Parental/caregiver anxiety, was assessed using the validated State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. The STAI is compromised of separate self-report scales for measuring state and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel "right now, at this moment". The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how respondents generally feel. The score ranges from 20 (most relaxed) to 80 (highest stress). The baseline STAI inventory was completed by e parent/caregiver after obtaining the informed consent in the preoperative holding area and before the subject was separated from the caregiver. Baseline STAI inventory consisted of form STAIY-1 (State Anxiety) and form STAIY-2 (Trait Anxiety) anxiety. After caregiver/patient separation,form STAIY-1(State Anxiety) was completed again by the caregiver.	Preoperative holding area from the time of informed consent until caregiver/patient separation.

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Amgad Hanna, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2014
• Primary Completion (Actual): May 6, 2016
• Study Completion (Actual): May 6, 2016

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pre-medication; Pre-operative anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Midazolam; Zolpidem
• Other Study ID Numbers: 5140032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No