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Completed

NCT Number: NCT05971485

Melatonin As an Analgesic in Preterm Neonate

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.

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Key information

Conditions

Preterm Neonate Analgesia Agnosia Female Urogenital Diseases and Pregnancy Complications Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Perceptual Disorders Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine - Ain Shams University

Cairo, Egypt

About this study

This is a randomized, double-blind, controlled trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Other

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

Primary outcomes

  1. Evaluate the analgesic effect of melatonin in preterm

    Time frame: 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

  2. Malondialdehyde (MDA), marker of oxidative stress

    Time frame: 60 minutes of the procedure

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Melatonin As an Analgesic in Preterm Neonate

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2023
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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