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role of melatonin as premedication

Registration number：

ITMCTR2023000044

Date of Last Refreshed on：

2023-09-12

Date of Registration：

2023-09-12

Registration Status：

Prospective registration

Public title：

role of melatonin as premedication

English Acronym：

MT(melatonin)

Scientific title：

Efficacy of Melatonin as a Premedication in Children Undergoing Elective Surgery, a double-blinded randomized trial

Scientific title acronym：

MT(melatonin)

Study subject ID：

The registration number of the Partner Registry or other register：

The Universal Trial Number (UTN) is U1111-1297-5376 ;

Applicant：

haider albareh

Study leader：

DR. Mohammed kahlol

Applicant telephone：

009647807225250

Study leader's telephone：

009647601440326

Applicant Fax：

Study leader's fax：

Applicant E-mail：

haideralbareh@gmail.com

Study leader's E-mail：

smtc_hilla2004@yahoo.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Iraq-Babil- Hilla

Study leader's address：

Iraq- Babil Hilla

Applicant postcode：

00964

Study leader's postcode：

00964

Applicant's institution：

MINSTRY OF IRAQI HEALTH-Babil teaching hospital for maternity and children

Approved by ethic committee：

Approved No. of ethic committee：

(Ref. NO. 59/08/2023)

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethical committee in ministry of health in Iraq

Date of approved by ethic committee：

2023/8/10 0:00:00

Contact Name of the ethic committee：

DR. Mohammed alkhafagy

Contact Address of the ethic committee：

Iraq- Babil -HILLA

Contact phone of the ethic committee：

009647825021455

Contact email of the ethic committee：

smtc_hilla2004@yahoo.com

Primary sponsor：

institute research

Primary sponsor's address：

Iraq-Babil- Hilla

Secondary sponsor：

Country：

iraq

Province：

babil

City：

hilla

Institution
hospital：

Babil teaching hospital for maternity and children

Address：

babil-hilla

Source(s) of funding：

by my self

Target disease：

anxiety in children undergoing elective surgery

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Phase II clinical trial

Objectives of Study：

we aimed to compare the effect of two different doses as premedication's on anxiety before anesthesia induction in children scheduled for elective surgery.

Description for medicine or protocol of treatment in detail：

The children received oral melatonin either 0.2mg kg or 0.4 mg/kg max 10 mg . Oral melatonin was available as a pale brown viscous syrup (12.5 mg per 5 ml). The calculated dose was prepared and administered 45 min prior to anesthesia induction in a 5 ml syringe by a nurse trainee not involved in the conduct of the assessment of study outcomes. This ensured blinding of children, their families, the anesthesia team and the investigating team to the study drug. The allocation sequence de-coded after completion of the study

Inclusion criteria

Patients of either sex in age group 4–14 years with ASA I and II undergoing elective surgery

Exclusion criteria：

Non-inclusion criteria were pediatric patients with ASA III or more,

Study execute time：

From 2023-09-30

To      2023-11-30

Recruiting time：

From 2023-11-30

To      2023-12-30

Interventions：

63

Group：

M2

Sample size：

Intervention：

melatonin 0.2 mg/kg

Intervention code：

63

Group：

M4

Sample size：

Intervention：

melatonin 0,4 mg /kg

Intervention code：

Total sample size ： 126

Countries of recruitment
and research settings：

Country：

iraq

Province：

babil

City：

hilla

Institution/hospital：

Babil teaching hospital for maternity and children

Level of the institution：

tertiary hospital

Country：

iraq

Province：

babil

City：

city

Institution/hospital：

Babil teaching hospital for maternity and children

Level of the institution：

tertiary hospital

Outcomes：

Outcome：

anxiety score,

Type：

Primary indicator

Measure time point of outcome：

30-45 min after medication

Measure method：

modified yale preoperative anxiety short form (mYPAsf))

Outcome：

parent separation score

Type：

Additional indicator

Measure time point of outcome：

when entry to the operative room

Measure method：

Child–Parent Separation Score(CPSS)

Outcome：

sedation scale

Type：

Secondary indicator

Measure time point of outcome：

30-45 min after medication

Measure method：

ramsy sedation score(RSC)

Collecting sample(s)
from participants：

Not yet recruiting

4
Min age years
14
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The individuals were enrolled and randomized into two groups based on a computer-generated block randomization process with the allocation sequence concealed in sequentially numbered, opaque, sealed envelopes.

Blinding：

Double blind randomized clinical trial

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://orcid.org/0009-0005-3486-8718

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

SPSS is used to analyze the data. Continuous data are expressed as mean  SD or median [IQR] based on the normality of distribution as checked by the Shapiro–Wilk test. Frequency and percentage is calculated for categorical data. The baseline data is compared using one-way analysis of variance

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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