Breastmilk Alone or in Combination With Paracetamol for Reducing Pain

Phase 4

• Conditions: Pain Control
• Interventions: Drug: Paracetamol

• Registration Number: NCT05354479
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

Efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening.

Detailed Description

Retinopathy of prematurity (ROP) has been widely acknowledged to be the primary cause of preventable childhood blindness in developing countries. However, the procedure for screening is extremely painful. In this study, we will attempt to relieve the pain experienced by these babies using breast milk alone or in combination with oral paracetamol. This randomized control trial study will be conducted with the aim to assess the efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening. All preterm neonate who undergone ROP screening will be the study population. A total of 60 preterm neonates will be randomized into three groups: (Group A - control group = 20, Group B - breast milk group = 20, and Group C - oral paracetamol + breast milk = 20). Group A will get current care as per institutional protocol, Group B received 2 ml expressed breast milk (EBM) through a sterile syringe orally 2 min prior to procedure, Group C received syrup paracetamol, 15 mg/kg 30 min prior to procedure and EBM as in Group B. Pain experienced was measured by the premature infant pain profile (PIPP) score 20 s prior, during and 2 min after procedure. All procedures were video recorded. The Ophthalmologist and analyzer both will be blinded to the intervention. Results will be incorporated after enrollment

Study Timeline

• Study Start: 2021-10-20
• Status Verified: 2022-04
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Gestational age <35 weeks, and birth weight <2000 gm

Exclusion Criteria

• 1. Parents of neonate who refused to participate in the study 2. Newborns with multiple congenital anomalies 3. Patient who is on mechanical ventilator during ROP examination 4. Neonate receiving narcotic or sedative drugs 5. Neonate not receiving oral feed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paracetamol plus expressed breast milk	Paracetamol	Babies will get expressed breast milk plus paracetamol
Expressed breast milk	Paracetamol	Babies will get only expressed breast milk.

Primary Outcome Measures

Name	Time	Method
Decrease in pain	6 months	Premature Infant Pain Score

Trial Locations

Locations (1)

BSMMu; 🇧🇩 Dhaka, Bangladesh