Is morphine an effective analgesic for procedural pain in infants?

Phase 2

• Conditions: Topic: Children; Subtopic: Pain; Signs and Symptoms

• Registration Number: ISRCTN82342359
• Lead Sponsor: Research Services, University of Oxford

Brief Summary

2016 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28066825/ protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30509743 results 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31483590/ (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-29
• Study Completion: 2018-03-15
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Participants will be in-patients on the neonatal unit at the John Radcliffe Hospital, Oxford
2. Infants born less than 32 weeks’ gestation or birth weight <1501 g
3. At the time of study, infants will be between 34 and 42 weeks gestational age (GA) and will be studied if they require a clinical heel lance and retinopathy of prematurity (ROP) screening on the same test occasion. We will study infants during a single ROP examination when they are greater than or equal to 34 weeks’ gestation
4. Infants for whom parents/guardians have consented to inclusion in the trial.; Upper Age Limit 42 weeks
Lower Age Limit 34 weeks
5. Senior clinician considers inclusion in trial to be medically appropriate (added 04/02/2016)

Exclusion Criteria

1. Intraventricular haemorrhage > grade II
2. Short bowel syndrome
3. Receiving nil by mouth due to documented gut pathology
4. Received opiates in the last 72 hours
5. Received other analgesics or sedatives in the last 24 hours
6. Previously documented episode of morphine sensitivity
7. Congenital malformation or genetic condition known to affect neurological development
8. Senior clinician considers inclusion in trial to be medically appropriate
9. Born to mothers who regularly use opiates during pregnancy or while breastfeeding or expressing breast milk

Study & Design

• Study Type: Interventional
• Study Design: Not specified