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oral melatonin in neonatal procedural pain

Effect of Oral Melatonin compared to sucrose 24% in neonatal procedural Pain

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202407517097387
Enrollment
60
Registered
2024-07-01
Start date
2024-05-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Diseases

Interventions

group A
group B

Sponsors

kafr el sheikh university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Newborn infants admitted to NICU who will undergo any type of minor procedure and expected to suffer from moderate to severe procedural pain. These procedures include the following: 1- Wound treatment. 2- Incision and drainage. 3- Lumbar puncture. 4- Peripheral arterial line. 5- PICC line placement. 6- Central venous line placement. 7- Umbilical venous catheter placement. 8- Chest tube insertion

Exclusion criteria

Exclusion criteria: 1- Newborn infants who receive opioid infusion or deep sedation. 2- Neurological condition that may affect pain sensation. 3- Congenital anomalies of the brain. 4- Inborn Error of metabolism.

Design outcomes

Primary

MeasureTime frame
The neonatal pain will be assessed using a validated composite pain measurement - The NIPS, which is commonly used to monitor a neonate before, during, and after a painful procedure The NIPS score is rated on the expression of the face (0, 1), cry (0–2), breathing patterns (0, 1), arms (0, 1), legs (0, 1), and state of arousal (0, 1). The total score ranges from 0 to 7. A score >3 indicates clinically significant pain (J Lawrence et al., 1993). -The N-PASS scale another validated composite measure for neonatal pain (Hummel P et al., 2010)

Secondary

MeasureTime frame
correlation between pain scores and type of procedure in both study groups.

Countries

Egypt

Contacts

Public Contactsara abdelgawad

resident of pediatrics

sara@yahoo.com00201063389003

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026