Procedural analgesia for pain during retinopathy of prematurity screening in preterm infants: A Multi-arm, Parallel group, Randomized Controlled trial comparing Multisensory stimulation, oral paracetamol, and control
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- 1. To compare the mean scores of pain severity of MSS and the Control group using the PIPP-R scale during the below 10 described stages.
Study Overview
Brief Summary
ÂScreening for Retinopathy of prematurity (ROP) in preterm infants is one of the most painful procedures. Non-pharmacological methods like, expressed breast milk (EBM), non-nutritive sucking (NNS), facilitated tucking, and swaddling, and pharmacological methods like topical analgesia alone or with oral paracetamol, intranasal fentanyl, and morphine have been studied for analgesia for pain during ROP screening.
Previous studies (only 4 studies) on oral paracetamol for pain during ROP screening, have shown varied results from significant to no effect. As per our literature search till now, there are very few (Only 2) studies on the effect of Multi-Sensory Stimulation (MSS) on pain during ROP screening. Also, we could not find any studies comparing the efficacy of the non-pharmacological modality of MSS versus oral Paracetamol for pain during ROP screening. Hence, this multi-arm trial aims to study the effect of MSS and oral Paracetamol against the control of Topical analgesia, which is a standard recommendation by various governing bodies, and also compare the efficacy of efficacy non-pharmacological modality of MSS versus oral Paracetamol for pain during ROP screening.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 14.00 Day(s) to 60.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Neonates who will be undergoing ROP screening as per ILROP-3 recommendation for the first time.
Exclusion Criteria
- •Infants with IVH 3 or more
- •Infants on a mechanical ventilator, inotropes, sedatives
- •Infants who underwent any surgery
- •Major congenital anomalies.
- •cardiac, neurological, facial palsy
- •Those infants whose mothers will not be available during the intervention
- •Infants whose parents do not consent to participate in the trial.
Outcomes
Primary Outcomes
1. To compare the mean scores of pain severity of MSS and the Control group using the PIPP-R scale during the below 10 described stages.
Time Frame: - 30 seconds before examination | - During the examination of the 1st eye | - During the examination of the 2nd eye | - 30 seconds after the end of the examination | - 1 minute after the end of the examination | - 1.5 minutes after the end of the examination | - 2 minutes after the end of the examination | - 5 minutes after the end of the examination | - 30 minutes after the end of the examination | - 1 hour after the end of the examination
2. To compare the mean scores of pain severity of oral Paracetamol and the Control group using the PIPP-R scale during the below 10 described stages.
Time Frame: - 30 seconds before examination | - During the examination of the 1st eye | - During the examination of the 2nd eye | - 30 seconds after the end of the examination | - 1 minute after the end of the examination | - 1.5 minutes after the end of the examination | - 2 minutes after the end of the examination | - 5 minutes after the end of the examination | - 30 minutes after the end of the examination | - 1 hour after the end of the examination
Secondary Outcomes
- 4. To compare the total cry time post-procedure- Between MSS and control groups; Between oral paracetamol and control groups; Between MSS and oral paracetamol group
- 1. To compare the mean scores of pain severity between the MSS and oral Paracetamol groups using the PIPP-R scale during the 10 described stages(- 30 seconds before examination)
- 2. To compare the trend of mean scores of pain severity using the PIPP-R scale of all the three groups during the 10 described stages.(- 30 seconds before examination)
- 3. To compare the mean pain scores using the NIPS Pain Scale- Between MSS and control groups; Between oral paracetamol and control groups; Between MSS and oral paracetamol groups
Investigators
Dr Mounika B
Instiute of Child Health and Hospital for Children, Madreas Medical College.