A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Status:
Completed
Trial end date:
2016-05-06
Target enrollment:
Participant gender:
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.