A Phase 2 interventional study of Melatonin 10 mg and Placebo in Preterm Neonate Analgesia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
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.
This is a randomized, double-blind, controlled trial
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Exclusion Criteria:
Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.
Drug: Melatonin 10 mg
Preterm neonates will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.
Other: Placebo
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
The placebo group will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.
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
Time frame: 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
Time frame: 60 minutes of the procedure
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Ain Shams University