None listed
Conditions
Brief summary
Preterm infants, particularly those born before 31 weeks, are at risk of incurable blindness from a condition called retinopathy of prematurity (ROP). Regular screening eye examinations in the neonatal intensive care units (NICU) monitor for ROP disease. Unfortunately, these eye examinations are painful and stressful, and research has shown that untreated stress in preterm infants leads to adverse neurodevelopment and even mental health problems. Currently there is no effective and safe way of reducing distress from eye examinations. In this study, we propose using a medication, dexmedetomidine for pain relief for the ROP eye checks. Dexmedetomidine is used increasingly for sick babies in NICUs, usually intravenously (which is painful and distressing in itself). We plan to give dexmedetomidine intranasally(via a special nasal spray device) as well as the usual standard comfort measures and compare pain scores and other physiological parameters such as oxygen levels, heart rates and breathing rates from this group of babies to those who will receive usual comfort strategies used during standard ROP eye examinations. We hypothesise that intranasal dexmedetomidine would reduce infant discomfort and improve infant physiological parameters including oxygenation.
Interventions
Babies undergoing routine Retinopathy of Prematurity (ROP) examinations > post 32 weeks gestation will have their examination recorded via a video camera. This recording will be set up prior to each examination and will record footage of the infant and the vitals monitoring screen 5 mins prior, during and up until 5 mins post procedure. This will be attended by the neonatal research nurse. The clinician performing the assessments from the video footage will be blinded to which infants received
Babies undergoing routine Retinopathy of Prematurity (ROP) examinations > post 32 weeks gestation will have their examination recorded via a video camera. This recording will be set up prior to each examination and will record footage of the infant and the vitals monitoring screen 5 mins prior, during and up until 5 mins post procedure. This will be attended by the neonatal research nurse. The clinician performing the assessments from the video footage will be blinded to which infants received the intervention. Infants allocated to the intervention group will receive standard comfort interventions during the ROP examination plus the addition of 1mg/kg of Intranasal dexmedetomidine 30 mins prior to the examination by the research nurse. Intranasal dexmedetomidine will be prescribed and signed for post administration on a stand alone prescription chart that will be kept seperate to the medication chart used by the ROP examination team for prescribing the routine ROP eye examination medications. Standard comfort measures include: 1. Containment 10mins prior, during and 5 mins post examination 2. Sucrose 24% 0.2ml via a syringe 2mins before, and at 5mins and 10min intervals once the procedure has begun 3. Oxybuprocaine 0.4% 1 drop each eye immediately prior to examination
Sponsors
Renee Muirhead- Mater Mothers Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
23 Weeks to 40 Weeks
Healthy volunteers
No
Inclusion criteria
• Infants born less than 32 weeks gestation and who are approaching >32 weeks PMA (age at which ROP screening commences) • Infants scheduled for routine retinopathy of prematurity eye examination • Parents/guardians provide written informed consent.
Exclusion criteria
• Major congenital anomalies • Severe intraventricular haemorrhage (Grade III/IV) • Hypotension requiring inotropes • Known hypersensitivity to dexmedetomidine • Already receiving sedative or opioid medications
Outcome results
None listed