Clinical trial NCT02096900: A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Official title: A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parental/Caregiver Anxiety
Child's Anxiety
Keywords: Pre-medication
Pre-operative anxiety
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 86
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Patient Anxiety at the Time of Separation
timeFrame: Up to 24 hours including preoperative, preoperative, and postoperative periods.
Secondary outcomes:
measure: Mask Acceptance Score
timeFrame: During induction of general anesthesia.
measure: Presence of Emergence Delirium During Recovery
timeFrame: Up to 30 minutes after child's first eye opening in the post-operative period.
measure: Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)
timeFrame: Preoperative holding area from the time of informed consent until caregiver/patient separation.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Amgad Hanna, MD
role: PRINCIPAL_INVESTIGATOR
References: