Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Effect of Drug
- Sponsor
- Minia University
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- The compliance to anesthesia induction in pediatric patients.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy
Detailed Description
The aim of the study is to compare the effectiveness of preoperative oral melatonin and hydroxyzine on preoperative anxiety in pediatric patients undergoing adenotonsillectomy. The primary outcomes: 1. Ease of parenteral separation. 2. The compliance to anesthesia induction in pediatric patients. The secondary outcomes: 1. Assessment of postoperative pain. 2. Time to first analgesic request.
Investigators
Sarah Mohamed Aly Omar Mousa
Dr
Minia University
Eligibility Criteria
Inclusion Criteria
- •ASA: class l
- •Sex: male and female
- •Age: from 3 to 10 years old
- •Children scheduled for adenotonsillectomy
Exclusion Criteria
- •All children with a history of chronic illness, or developmental delay were excluded from the study
- •History of an autoimmune disease
- •Concurrent use of immunosuppressive treatment
- •Sleep disturbances, speech or communication problems
- •allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine.
- •hydroxyzine is contraindicated in patients with acute porphyria
Arms & Interventions
placebo
10ml apple juice one hour before induction of anesthesia
Intervention: Placebo
Melatonin
Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia
Intervention: Melatonin 3 MG
Hydroxyzine
Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia
Intervention: Hydroxyzine Pill
Outcomes
Primary Outcomes
The compliance to anesthesia induction in pediatric patients.
Time Frame: one hour after administration
Assessed by a modified Yale preoperative anxiety scale, the range is from 5 to 22, the lower score is better
Ease of parenteral separation.
Time Frame: 20-30 minutes after administration
Recorded as excellent, good, fair, or poor when the child is separated from the parent
Secondary Outcomes
- First analgesic request(Three hours postoperative)
- Assessment of postoperative pain(immediately before and at induction procedure)