Melatonin As an Analgesic in Preterm Neonate

Phase 2

Completed

• Conditions: Preterm Neonate Analgesia
• Interventions: Drug: Melatonin 10 mg; Other: Placebo

• Registration Number: NCT05971485
• Lead Sponsor: Ain Shams University

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, 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 enteral melatonin given 30 minutes before cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Additionally, the study aimed to explore the relationship between procedural pain and oxidative stress, along with the effectiveness of pain management of melatonin by measuring Malondialdehyde (MDA), a well-accepted marker of oxidative stress, 60 minutes after the procedure.

Detailed Description

This is a randomized, double-blind, controlled trial

Study Timeline

• Study Start: 2022-08-20
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-02
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-30
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin group	Melatonin 10 mg	Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.
Placebo group	Placebo	Preterm neonates will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine - Ain Shams University; 🇪🇬 Cairo, Egypt