The Premedication Properties of Oral Melatonin in Pediatrics Undergoing Therapeutic Cardiac Catheterization

NCT06031961 | Unknown

• 1 other identifier: Melatonin in PA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The evaluation of oral melatonin efficacy as premedicant agent in pediatrics undergoing elective cardiac interventions is the primary outcomes of our trail.

Conditions

Anesthesia

Keywords

Melatonin, premedication, preoperative anxiety

Outcome Measures

Primary Outcomes (1)

• preoperative anxiety

  Modified Yale Preoperative Anxiety Scale (mYPAS)

  30 minutes before 2nd dose of premedication, 1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.

Secondary Outcomes (1)

• Sedation level

  1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.

Study Arms (2)

1st group: Melatonin group

ACTIVE COMPARATOR

All children in this group have to receive 0.5 mg/kg of melatonin(maximum dose 20 mg) which will be administered orally on the night before surgery ( at 12 am) and immediately before 30 minutes before entering the catheterization room.

Drug: melatonin

2nd group: Placebo group

PLACEBO COMPARATOR

All children in this group have to receive a placebo which will be administered orally on the night before surgery and immediately before 30 minutes before entering the catheterization room.

Drug: melatonin

Interventions

melatonin DRUG

We will premedicate the children whom involved in the 1st group with 0.5 mg/kg oral melatonin in the midnight before surgery and the dose will be repeated at morning before getting in the catheterization room

Also known as: Placebo

1st group: Melatonin group; 2nd group: Placebo group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 4-12 years.
• scheduled for elective therapeutic cardiac catheterization
• ASA I and II

You may not qualify if:

• ASA III or more than.
• Drug allergy.
• Any of contraindication for general anesthesia.
• Mental and neurological diseases.
• disapproval or dissatisfaction
• Liver disease
• Diabetic children
• Thyroid storm
• Sleep disorders
• Intake of antipsychotics.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Ministry of Health

Baghdad, Thi-Qar, 00964, Iraq

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mohamed kahloul, professor

  souse university

  STUDY CHAIR

Central Study Contacts

Hussein Hussein

CONTACT

009647811593388; hussein.hussein@alayen.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in anesthesiology department

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: September 11, 2023
• Study Start: September 10, 2023
• Primary Completion: May 15, 2024
• Study Completion: August 15, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)