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

Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Effect of Drug
• Intervention / Treatment: Drug: Melatonin 3 MG; Drug: Hydroxyzine Pill; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sarah Omar, M.D.; Phone Number: +20100537617; Email: sara.mohamed@mu.edu.eg
• Study Contact Backup: Name: Hanafy

Study Locations

• Egypt
  • Al Minyā, Egypt, 61111
    • Recruiting
    • Sarah Omar
    • Contact: Sarah Omar; Phone Number: +20100537617; Email: sara.mohamed@mu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Melatonin; Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia	Drug: Melatonin 3 MG; 0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia; Other Names: Melatonin
Active Comparator: Hydroxyzine; Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia	Drug: Hydroxyzine Pill; 1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia; Other Names: Atarax 10mg
Placebo Comparator: placebo; 10ml apple juice one hour before induction of anesthesia	Other: Placebo; 10 ml apple juice 1 hour before induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of parenteral separation.	Recorded as excellent, good, fair, or poor when the child is separated from the parent	20-30 minutes after administration
The compliance to anesthesia induction in pediatric patients.	Assessed by a modified Yale preoperative anxiety scale, the range is from 5 to 22, the lower score is better	one hour after administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Study Director: Sarah Omar, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Melatonin; Pediatric; Adenotonsillectomy; Preoperative Anxiety; Hydroxyzine
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Dermatologic Agents; Antioxidants; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Melatonin; Hydroxyzine
• Other Study ID Numbers: 505/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: May share when the study is completed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No