NCT05680584

Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Effect of Drug
• Anxiety

Interventions

Type	Name	Description
DRUG	Melatonin 3 MG	0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia
DRUG	Hydroxyzine Pill	1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia
OTHER	Placebo	10 ml apple juice 1 hour before induction of anesthesia

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2023-01-11
• Last updated: 2023-12-27

Locations

1 site across 1 country: Egypt