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A Blind Randomized Trial Comparing Different Doses of Oral Melatonin with Placebo as Premedication in Pediatrics to Alleviate Preoperative Anxiety

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Last updated: 25 Feb 2025

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Abstract

Background and objectives: In children, preoperative anxiety in is known to be associated with different postoperative issues, such as regressive behavioral changes, prolonged recovery distress, eating disorders, and bedwetting. Administering pre-anesthetics and sedatives orally is a reliable method for children. This study aimed to evaluate the effectiveness of two different doses of melatonin premedication in reducing preoperative anxiety in children. Methods: A double-blind randomized study, carried out after ethical committee approving, and involved 120 children aged 4–10 years, classified as American Society of Anesthesiologists physical status I or II, undergoing elective surgery under general anesthesia in the pediatric surgery department in Bent-Alhuda Teaching Hospital in Al Nasiriya city from July 2023 to the end of January 2024. Participants were randomly assigned into three groups of 40 patients (Groups M04, M02, and Placebo) to receive either oral melatonin 0.4 mg/kg, 0.2 mg/kg, or identical placebo premedication 60 minutes before induction. Anxiety levels were assessed 15 minutes before premedication, 45 minutes after premedication, and during parental separation, while sedation levels were evaluated at three-time points, all after the premedication was administered. Results: The three study groups were comparable in terms of mean age, weight, sex, and duration of anesthesia. Following premedication, the M04 group showed a significant reduction in anxiety levels compared to levels in both M02 and placebo groups, with a statistically significant difference (p > 0.05). In all time points of assessment, the sedation levels in the M04 group were significantly higher than those in both the M02 and placebo groups. In contrast, the difference between the M02 and placebo groups was insignificant (p > 0.05). regarding the hemodynamics; we found the measured hemodynamics were closer to the normal levels in the M04 group while in the other two groups, they were not. Conclusion: Administering oral melatonin at a dose of 0.4 mg/kg appears to be more effective than a dose of 0.2 mg/kg or placebo premedication for reducing preoperative anxiety in children during separation from their parents in the preoperative area.

DOI

10.21608/ejhc.2025.413807

Keywords

 General Anesthesia, Oral Melatonin, Pediatrics, placebo, Premedication, preoperative anxiety, Sedation

Authors

First Name

Hussein

Last Name

Ali Hussein

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Affiliation

Department of Anesthesia, College of Health and Medical Technology, Al-Ayen Iraqi University, Thi-Qar, 64001, Iraq.

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Orcid

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First Name

Frqad

Last Name

Salih Jawad

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Affiliation

Anesthesia Techniques Department, College of Health and Medical Techniques, Al-Mustaqbal University, 51001, Babylon, Iraq.

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Orcid

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First Name

Ahmed

Last Name

Neamah Abed

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Affiliation

Anesthesia Techniques Department, College of Health and Medical Techniques, Al-Mustaqbal University, 51001, Babylon, Iraq.

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Orcid

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First Name

Mohammed

Last Name

Jasim khulaif

MiddleName

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Affiliation

Anesthesia Techniques Department, College of Health and Medical Techniques, Al-Mustaqbal University, 51001, Babylon, Iraq.

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Orcid

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First Name

Saad

Last Name

AbdulRaheem Hussein Aljuboori

MiddleName

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Affiliation

Anesthesia Techniques Department, College of Health and Medical Techniques, Al-Mustaqbal University, 51001, Babylon, Iraq.

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Orcid

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First Name

Ali.

Last Name

R Ali

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Affiliation

Al Zahraa Consultant Center for Allergy and Asthma, Baghdad, Al Karkha, Iraq.

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Orcid

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First Name

ALagha

Last Name

Muataz Fouad Hasan

MiddleName

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Affiliation

Higher Diploma in Anaesthesiology and ICU, College of Medical and Health Technologies, Al-Zahraa University for Women, Karbala 56100, Iraq.

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City

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Orcid

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First Name

Abbas

Last Name

K. Mohammed

MiddleName

-

Affiliation

Balad-Ruz General Hospital, Diyala Health Directorate, Ministry of Health, Iraq.

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Orcid

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First Name

Abbas

Last Name

H. Gatea

MiddleName

-

Affiliation

Thi-Qar Internists Association, 64001Iraq.

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Orcid

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First Name

Ali

Last Name

Nima Hasan

MiddleName

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Affiliation

Consultant Anesthesiology at Al_Sader Teaching Hospital. Najaf, Iraq.

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Orcid

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First Name

Hussein

Last Name

Alkhfaji

MiddleName

-

Affiliation

Department of Anesthesia, College of Health and Medical Technology, Al-Ayen Iraqi University, Thi-Qar, 64001, Iraq.

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City

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Orcid

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First Name

Neveen

Last Name

A. Kohaf

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Affiliation

Department of Anesthesia, College of Health and Medical Technology, Al-Ayen Iraqi University, Thi-Qar, 64001, Iraq.

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Orcid

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First Name

Majid

Last Name

F. Alhamaidah

MiddleName

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Affiliation

Department of Clinical Pharmacy, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt, 11651.

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Orcid

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First Name

Mohammed

Last Name

AbdulZahra Sasaa

MiddleName

-

Affiliation

Anesthesia Techniques Department, College of Health and Medical Techniques, Al-Mustaqbal University, 51001, Babylon, Iraq.

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City

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Orcid

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First Name

Rania

Last Name

Abd Elmohsen Abo El Nour

MiddleName

-

Affiliation

Anesthesia Techniques Department, College of Health and Medical Techniques, Al-Mustaqbal University, 51001, Babylon, Iraq. and Community Health Nursing Department, Beni-Suef Health Technical Institute, Ministry of Health, 62511, Egypt.

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Volume

16

Article Issue

1

Related Issue

51995

Issue Date

2025-03-01

Receive Date

2025-02-23

Publish Date

2025-03-01

Page Start

450

Page End

458

Print ISSN

1687-9546

Online ISSN

3009-6766

Article File

EJHC_Volume 16_Issue 1_Pages 450-458.pdf

PDF . 205.8kB

Link

https://ejhc.journals.ekb.eg/article_413807.html

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http://journals.ekb.eg?_action=service&article_code=413807

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413,807

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Original Article

Type Code

631

Publication Type

Journal

Publication Title

Egyptian Journal of Health Care

Publication Link

https://ejhc.journals.ekb.eg/

MainTitle

A Blind Randomized Trial Comparing Different Doses of Oral Melatonin with Placebo as Premedication in Pediatrics to Alleviate Preoperative Anxiety

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Article

Created At

25 Feb 2025