Breastmilk Alone or in Combination With Paracetamol for Reducing Pain

Pain Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05354479
• Other study ID #: 585
• Status: Recruiting
• Phase: Phase 4
• Start date: October 20, 2021
• Est. completion date: April 19, 2022

Study information

• Verified date: April 2022
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: Rumpa Mani Chowdhury, FCPS,MD
• Phone: +8801816356807
• Email: rumpamonichowdhury[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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.

Related Conditions & MeSH terms

• Pain Control

Intervention

Drug:
• Paracetamol
babies will get expressed breast milk along with paracatamol for pain relief

Locations

Country	Name	City	State
Bangladesh	BSMMu	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in pain	Premature Infant Pain Score	6 months