Screening for Retinopathy of Prematurity is an essential yet painful routine test that is performed multiple times in infants who are born prematurely. Premature infants also regularly require heel lance for blood tests. We will conduct a randomised placebo-controlled trial to examine whether morphine is an effective analgesic for these procedures.
Conditions
Interventions
Product Name: Morphine sulphate Oral solution 200mcg in 1mL
Product Code: n/a
Pharmaceutical Form: Oral solution
INN or Proposed INN: morphine sulphate 200mcg in 1ml oral solution
Concentration unit
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will be conducted in the neonatal unit at the John Radcliffe Hospital, Oxford. Inclusion Criteria • Participants will be in-patients on the neonatal unit at the John Radcliffe Hospital, Oxford. • Infants born less than 32 weeks’ gestation or birth weight =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion Criteria: • intraventricular haemorrhage > grade II • short bowel syndrome • receiving nil by mouth due to documented gut pathology • received opiates in the last 72 hours • received other analgesics or sedatives in the last 24 hours • previously documented episode of morphine sensitivity • congenital malformation or genetic condition known to affect neurological development • born to mothers who regularly use opiates during pregnancy or while breastfeeding or expressing breast milk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether administration of morphine reduces clinical pain scores (PIPP-R) compared with a placebo (inactive solution) 30 seconds after an eye examination to test for retinopathy of prematurity (ROP). To test whether administration of morphine reduces pain-related brain activity compared with a placebo (inactive solution) following a clinically-essential heel lance. ;Secondary Objective: To test whether administration of morphine improves clinical stability after ROP screening in the 6-hour and 24-hour period following the start of the examclinical intervention (heel lance followed by retinopathy of prematurity (ROP) screening). To test whether administration of morphine reduces clinical pain scores (PIPP-R) and motor reflex withdrawal activity compared with a placebo (inactive solution) following a clinically-essential heel lance compared with a placebo (inactive solution). To test whether administration of morphine is safe by determining whether it results in episodes of respiratory depression or hypotension that require intervention compared with a placebo. ;Primary end point(s): Primary outcome measure: Clinical pain score (PIPP-R) score 30seconds after ROP screening. Co-primary outcome measure: Magnitude of nociceptive-specific brain activity evoked by heel lance.;Timepoint(s) of evaluation of this end point: Primary outcome measure: 30 seconds after ROP screening Co-primary outcome measure: Immediately following heel lance | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Clinical stability in the 6-hour and 24-hour period following the start of the clinical intervention (heel lance followed by ROP screening). (Clinical stability assessment is calculated from pulse oximetry and blood pressure recordings and the need for increased respiratory support.) (2) Premature infant pain profile-Revised (PIPP-R) score and amplitude of reflex withdrawal following heel lance. (3) Drug safety will be assessed by calculating the number of incidences of apnoea that require intervention using NeoPuff or ‘bag and mask’ and the number of incidences of hypotension that requires treatment with inotropes in the 24-hour period following the administration of the IMP or placebo. ;Timepoint(s) of evaluation of this end point: (1) Clinical stability: 24-hours after ROP screening. (2) Premature infant pain profile-revised (PIPP-R) score and amplitude of reflex withdrawal: immediately following heel lance. (3) Drug safety: 24-hour period following the administration of the IMP or placebo. | — |
Countries
United Kingdom
Contacts
Public ContactMs Heather House
University of Oxford
Outcome results
None listed