A Comparison of Midazolam and Zolpidem as Oral Premedication in Children (PedsPreMed)
Primary Purpose
Parental/Caregiver Anxiety, Child's Anxiety
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
zolpidem
Midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Parental/Caregiver Anxiety focused on measuring Pre-medication, Pre-operative anxiety
Eligibility Criteria
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.
Sites / Locations
- Loma Linda University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
zolpidem
midazolam
Arm Description
zolpidem given orally 0.25mg/kg pre-operatively single dose
midazolam will be given at 0.5mg/kg, pre-operatively single dose
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02096900
Brief Title
A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Acronym
PedsPreMed
Official Title
A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 21, 2014 (Actual)
Primary Completion Date
May 6, 2016 (Actual)
Study Completion Date
May 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parental/Caregiver Anxiety, Child's Anxiety
Keywords
Pre-medication, Pre-operative anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
zolpidem
Arm Type
Active Comparator
Arm Description
zolpidem given orally 0.25mg/kg pre-operatively single dose
Arm Title
midazolam
Arm Type
Active Comparator
Arm Description
midazolam will be given at 0.5mg/kg, pre-operatively single dose
Intervention Type
Drug
Intervention Name(s)
zolpidem
Other Intervention Name(s)
ambien
Intervention Description
Zolpidem will be given one time at 0.25 mg/kg pre-operatively
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
versed
Primary Outcome Measure Information:
Title
Patient Anxiety at the Time of Separation
Description
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.
Time Frame
Up to 24 hours including preoperative, preoperative, and postoperative periods.
Secondary Outcome Measure Information:
Title
Mask Acceptance Score
Description
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.
Time Frame
During induction of general anesthesia.
Title
Presence of Emergence Delirium During Recovery
Description
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.
Time Frame
Up to 30 minutes after child's first eye opening in the post-operative period.
Title
Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)
Description
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.
Time Frame
Preoperative holding area from the time of informed consent until caregiver/patient separation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amgad Hanna, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
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