PatientsVille.com LogoPatientsVille.com

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?

Parental/Caregiver Anxiety

Child's Anxiety

Study Interventions

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

Drug:Midazolam

Study Arms

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

Study Status

Completed

Start Date: July 2014

Completed Date: May 2016

Phase: Phase 3

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02096900

Discuss Ambien