Skip to content

Oral Morphine for analgesia in neonates undergoing ROP screening

Oral Morphine for acute procedural pain in neonates undergoing ROP Screening â?? A Randomised Control Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/012926
Enrollment
100
Registered
2018-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Assessment of pain scores by PIPP tool for all inpatient babies undergoing ROP screening for the first time as per unit protocol.

Interventions

Intervention1: Oral morphine at dose of 100mcg/kg will be given 1 hour before procedure along with first tropicamide eye drops: Oral morphine solution will be given at 1ml/kg, prepared by pharmacology

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inpatient babies satisfying the unit ROP screening protocol and undergoing screening for first time will be included after getting a written consent from parents / caretakers.

Exclusion criteria

Exclusion criteria: 1. Babies on mechanical ventilator 2. Babies already on study drugs for any other reason 3. Breastfeeding mother in methadone or other analgesics 4. Babies with ileostomy / colostomy. 5. Babies kept NPO for other medical / surgical illness 6. Congenital anomalies

Design outcomes

Primary

MeasureTime frame
Mean pain score, (Median if not normally distributed) at 1 minute post procedure.Timepoint: 1 minute post procedure.

Secondary

MeasureTime frame
(i) Mean pain scores at 5min and 15min (ii) Adverse events will be recorded for 24 hours post procedure 1. Tachycardia (180 beats /min) 2. Apnea requiring intervention 3. Abdominal distension 4. Change in requirement of respiratory support (more than 20% increase in fio2 requirement, more than 10% increase in flow requirement, increase of 1 PEEP, new onset respiratory support or Mechanical ventilation requirement) Timepoint: 5 minutes , 15 minutes post procedure 24 hours monitoring for adverse events.

Countries

India

Contacts

Public ContactPrakash Vinayagam

Madras Medical College

dr_praky76@yahoo.com9968857025

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026