Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

Phase 1

Recruiting

• Conditions: Anxiety; Effect of Drug
• Interventions: Drug: Melatonin 3 MG; Drug: Hydroxyzine Pill; Other: Placebo

• Registration Number: NCT05680584
• Lead Sponsor: Minia University

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.

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-11
• Study Start: 2023-02-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. ASA: class l
2. Sex: male and female
3. Age: from 3 to 10 years old
4. Children scheduled for adenotonsillectomy

Exclusion Criteria

1. All children with a history of chronic illness, or developmental delay were excluded from the study

2. History of an autoimmune disease

3. Concurrent use of immunosuppressive treatment

4. Sleep disturbances, speech or communication problems

5. allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine.

6. hydroxyzine is contraindicated in patients with acute porphyria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin 3 MG	Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia
Hydroxyzine	Hydroxyzine Pill	Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia
placebo	Placebo	10ml apple juice one hour before induction of anesthesia

Primary Outcome Measures

Name	Time	Method
The compliance to anesthesia induction in pediatric patients.	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.	20-30 minutes after administration	Recorded as excellent, good, fair, or poor when the child is separated from the parent

Secondary Outcome Measures

Name	Time	Method
First analgesic request	Three hours postoperative	Paracetamol
Assessment of postoperative pain	immediately before and at induction procedure	Face, Leg, Activity, Cry, and Consolability (FLACC) Scale from 0 to 10, the lower score is better

Trial Locations

Locations (1)

Sarah Omar; 🇪🇬 Al Minyā, Egypt