Preterm Neonate Analgesia
Conditions
Keywords
Preterm, Analgesia, Melatonin, Oxidative stress
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
Interventions
DRUGMelatonin 10 mg
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
OTHERPlacebo
The placebo group will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed