Melatonin as an Analgesic in Preterm Neonate

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Melatonin as an Analgesic in Preterm Neonate

Conditions
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Preterm Neonate Analgesia

Intervention / Treatment
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* Drug: Melatonin 10 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Melatonin group<br>Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion. | Drug: Melatonin 10 mg<br>* 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<br>|
| Control group<br>Preterm neonates will undergo venous cannula insertion without giving melatonin before the procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin, Preterm, Analgesia, Oxidative stress