Melatonin As an Analgesic in Preterm Neonate

NCT05971485 | Completed Phase 2 FDA Drug

• 1 other identifier: FMASU MS 496/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Neonate Analgesia

Keywords

Preterm; Analgesia; Melatonin; Oxidative stress

Outcome Measures

Primary Outcomes (2)

• Evaluate the analgesic effect of melatonin in preterm

  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

  5 minutes starting just before cannula insertion to 5 minutes after the procedure

• Malondialdehyde (MDA), marker of oxidative stress

  Serum Malondialdehyde (MDA), a marker of oxidative stress through measuring serum MDA after 60 minutes of the procedure

  60 minutes of the procedure

Study Arms (2)

Melatonin group

EXPERIMENTAL

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

Drug: Melatonin 10 mg

Placebo group

PLACEBO COMPARATOR

Preterm neonates will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.

Other: Placebo

Interventions

Melatonin 10 mg DRUG

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

Melatonin group

Placebo OTHER

The placebo group will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.

Placebo group

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine - Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Premature Birth; Agnosia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: August 20, 2022
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: January 16, 2025

Record last verified: 2024-12

Locations

EG (1)