A Comparison of Midazolam and Zolpidem as Oral Premedication in Children



Status:Completed
Conditions:Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:2 - 9
Updated:3/16/2019
Start Date:July 21, 2014
End Date:May 6, 2016

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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.


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.
We found this trial at
1
site
Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Amgad Hanna, MD
Phone: 909-558-8493
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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from
Loma Linda, CA
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