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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02096900
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : August 11, 2017
Last Update Posted : March 14, 2019
Information provided by (Responsible Party):
Davinder Ramsingh, MD, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Parental/Caregiver Anxiety Child's Anxiety Drug: zolpidem Drug: Midazolam Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Actual Study Start Date : July 21, 2014
Actual Primary Completion Date : May 6, 2016
Actual Study Completion Date : May 6, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Caregivers

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 Name: ambien

Active Comparator: midazolam
midazolam will be given at 0.5mg/kg, pre-operatively single dose
Drug: Midazolam
Other Name: versed

Primary Outcome Measures :
  1. Patient Anxiety at the Time of Separation [ Time Frame: Up to 24 hours including preoperative, preoperative, and postoperative periods. ]

    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.

Secondary Outcome Measures :
  1. Mask Acceptance Score [ Time Frame: During induction of general anesthesia. ]

    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.

  2. Presence of Emergence Delirium During Recovery [ Time Frame: Up to 30 minutes after child's first eye opening in the post-operative period. ]
    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.

  3. Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI) [ Time Frame: Preoperative holding area from the time of informed consent until caregiver/patient separation. ]

    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02096900

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United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
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Principal Investigator: Amgad Hanna, MD Loma Linda University

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Responsible Party: Davinder Ramsingh, MD, Principal Investigator, Loma Linda University Identifier: NCT02096900    
Other Study ID Numbers: 5140032
First Posted: March 26, 2014    Key Record Dates
Results First Posted: August 11, 2017
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Davinder Ramsingh, MD, Loma Linda University:
Pre-operative anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sleep Aids, Pharmaceutical
GABA-A Receptor Agonists
GABA Agonists