A Comparison of Midazolam and Zolpidem as Oral Premedication in Children (PedsPreMed)
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|ClinicalTrials.gov Identifier: NCT02096900|
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : August 11, 2017
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parental/Caregiver Anxiety Child's Anxiety||Drug: zolpidem Drug: Midazolam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: zolpidem
zolpidem given orally 0.25mg/kg pre-operatively single dose
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
Other Name: versed
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02096900
|United States, California|
|Loma Linda University|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||Amgad Hanna, MD||Loma Linda University|