Breastmilk Alone or in Combination With Paracetamol for Reducing Pain

Efficacy of Expressed Breast Milk Alone or in Combination With Paracetamol in Reducing Pain During ROP Screening

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

Study Overview

• Status: Recruiting
• Conditions: Pain Control
• Intervention / Treatment: Drug: Paracetamol

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rumpa Mani Chowdhury, FCPS,MD; Phone Number: +8801816356807; Email: rumpamonichowdhury@gmail.com

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Recruiting
    • BSMMU
    • Contact: Rumpa Mani Chowdhury, FCPS,MD; Phone Number: +8801816356807; Email: rumpamonichowdhury@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Expressed breast milk; Babies will get only expressed breast milk.	Drug: Paracetamol; babies will get expressed breast milk along with paracatamol for pain relief; Other Names: Breast milk
Experimental: paracetamol plus expressed breast milk; Babies will get expressed breast milk plus paracetamol	Drug: Paracetamol; babies will get expressed breast milk along with paracatamol for pain relief; Other Names: Breast milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in pain	Premature Infant Pain Score	6 months

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Anticipated): April 19, 2022
• Study Completion (Anticipated): April 19, 2022

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 585

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No