Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

Sponsor
Minia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05680584
Collaborator
(none)
78
1
3
3.9
19.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 3 MG
  • Drug: Hydroxyzine Pill
  • Other: Placebo
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three study groupsThree study groups
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Ease of parenteral separation. [20-30 minutes after administration]

      Recorded as excellent, good, fair, or poor when the child is separated from the parent

    2. 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

    Secondary Outcome Measures

    1. 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

    2. First analgesic request [Three hours postoperative]

      Paracetamol

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sarah Omar Al Minyā Egypt 61111

    Sponsors and Collaborators

    • Minia University

    Investigators

    • Study Director: Sarah Omar, Minia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sarah Mohamed Aly Omar Mousa, Dr, Minia University
    ClinicalTrials.gov Identifier:
    NCT05680584
    Other Study ID Numbers:
    • 505/2022
    First Posted:
    Jan 11, 2023
    Last Update Posted:
    Jan 11, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Sarah Mohamed Aly Omar Mousa, Dr, Minia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2023