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

Loma Linda University (LLU)

Status and phase

Completed

Phase 3

Conditions

Child's Anxiety

Parental/Caregiver Anxiety

Treatments

Drug: Midazolam

Drug: zolpidem

Study type

Interventional

Funder types

Other

Identifiers

NCT02096900

5140032

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

All

Ages

2 to 9 years old

Volunteers

No Healthy Volunteers

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.