Breastmilk Alone or in Combination With Paracetamol for Reducing Pain

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Unknown; Phase 4

Conditions: Pain Control

Treatments: Drug: Paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT05354479

585

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 20 days to 2 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Expressed breast milk

Active Comparator group

Description:

Babies will get only expressed breast milk.

Treatment:

Drug: Paracetamol

paracetamol plus expressed breast milk

Experimental group

Description:

Babies will get expressed breast milk plus paracetamol

Treatment:

Drug: Paracetamol