Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680584
• Other study ID #: 505/2022
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: December 2023
• Source: Minia University
• Contact: Sarah Omar, M.D.
• Phone: +20100537617
• Email: sara.mohamed[@]mu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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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Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Effect of Drug

Intervention

Drug:
• Melatonin 3 MG
0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia
• 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

Locations

Country	Name	City	State
Egypt	Sarah Omar	Al Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of parenteral separation.	Recorded as excellent, good, fair, or poor when the child is separated from the parent	20-30 minutes after administration
Primary	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	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
Secondary	First analgesic request	Paracetamol	Three hours postoperative