Parental/Caregiver Anxiety | A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Parental/Caregiver Anxiety research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:zolpidemZolpidem will be given one time at 0.25 mg/kg pre-operatively
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
zolpidemzolpidem given orally 0.25mg/kg pre-operatively single dose
midazolammidazolam will be given at 0.5mg/kg, pre-operatively single dose
Start Date: July 21, 2014
Completed Date: May 6, 2016
Phase: Phase 3
Primary Outcome: Patient Anxiety at the Time of Separation
Secondary Outcome: Mask Acceptance Score
Study sponsors, principal investigator, and references
Principal Investigator: Amgad Hanna, MD
Lead Sponsor: Loma Linda University