Melatonin as an Analgesic in Preterm Neonate

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05971485

Collaborator

(none)

Enrollment

Location

14.4

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, and antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of melatonin during venous cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure, and to demonstrate the significant relationship between procedural pain and Malondialdehyde (MDA), a well-accepted marker of oxidative stress through measuring MDA after 60 minutes of the procedure.

Condition or Disease	Intervention/Treatment	Phase
Preterm Neonate Analgesia	Drug: Melatonin 10 mg

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Efficacy of Melatonin as an Analgesic in Preterm Neonate

Actual Study Start Date :

Aug 20, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Melatonin group Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.	Drug: Melatonin 10 mg Melatonin 10 mg will be used. 5 mg·kg-1 dissolved in 2 ml of distilled water via enteral route in one single dose 30 minutes before the venous cannula insertion
Control group Preterm neonates will undergo venous cannula insertion without giving melatonin before the procedure.

Arm

Intervention/Treatment

Melatonin group

Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.

Drug: Melatonin 10 mg

Melatonin 10 mg will be used. 5 mg·kg-1 dissolved in 2 ml of distilled water via enteral route in one single dose 30 minutes before the venous cannula insertion

Control group

Preterm neonates will undergo venous cannula insertion without giving melatonin before the procedure.

Outcome Measures

Primary Outcome Measures

Evaluate the analgesic effect of melatonin in preterm [5 minutes starting just before cannula insertion to 5 minutes after the procedure]
Evaluate the analgesic effect of melatonin during venous cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Premature Infant pain Profile score (PIPP) scale 0-21, with 0-6 reflecting no pain, 6-12 reflecting mild-moderate pain, and above 12 indicating severe pain
Malondialdehyde (MDA), marker of oxidative stress [60 minutes of the procedure]
Serum Malondialdehyde (MDA), a marker of oxidative stress through measuring serum MDA after 60 minutes of the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 28 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Preterm infant
less than 37 weeks gestational age
who started enteral feeding.

Exclusion Criteria:

Multiple congenital anomalies.
Facial malformation.
Receiving analgesia or sedation.
Contraindication of enteral feeding.
Clinical or laboratory signs of sepsis.
Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine - Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ain Shams University

ClinicalTrials.gov Identifier:

NCT05971485

Other Study ID Numbers:

FMASU MS 496/2022

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Ain Shams University

Additional relevant MeSH terms:

Premature Birth

Melatonin

Study Results

No Results Posted as of Aug 7, 2023