Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

NCT05680584 | Unknown Phase 1 DMC

• 1 other identifier: 505/2022
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Effect of Drug; Anxiety

Keywords

Melatonin; Hydroxyzine; Preoperative Anxiety; Pediatric; Adenotonsillectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Assessment of postoperative pain

  immediately before and at induction procedure

• First analgesic request

  Three hours postoperative

Study Arms (3)

Melatonin

ACTIVE COMPARATOR

Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia

Drug: Melatonin 3 MG

Hydroxyzine

ACTIVE COMPARATOR

Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia

Drug: Hydroxyzine Pill

placebo

PLACEBO COMPARATOR

10ml apple juice one hour before induction of anesthesia

Other: Placebo

Interventions

Melatonin 3 MG DRUG

0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia

Also known as: Melatonin

Melatonin

Hydroxyzine Pill DRUG

1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia

Also known as: Atarax 10mg

Hydroxyzine

Placebo OTHER

10 ml apple juice 1 hour before induction of anesthesia

placebo

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA: class l
• Sex: male and female
• Age: from 3 to 10 years old
• Children scheduled for adenotonsillectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Sarah Omar

Al Minyā, 61111, Egypt

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Melatonin; Hydroxyzine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Piperazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sarah Omar

  Minia University

  STUDY DIRECTOR

Central Study Contacts

Sarah Omar, M.D.

CONTACT

+20100537617; sara.mohamed@mu.edu.eg

Hanafy

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Three study groups

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 11, 2023
• Study Start: February 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)