Pain relief following an acute noxious event in newborn infants Signs and Symptoms
Conditions
Interventions
Subjects will be allocated at random (randomisation ratio: 1:1) to receive one of two 0.5 ml solutions onto the tongue: 24% sucrose water (Sweet-Ease®) or sterile water (control). There is a 50% chanc
Sponsors
University College London Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In-patients on the labour ward, post-natal ward, transitional care unit (TCU) and special care baby unit (SCBU) at the Elizabeth Garrett Anderson & Obstetrics Hospital, University College London Hospital (UCLH), UK 2. Both males and females, aged between 37 and 45 weeks post-menstrual age (PMA) Babies will only be studied when a blood test is needed for clinical purposes.
Exclusion criteria
Exclusion criteria: Prior to each study the infant's well-being and their suitability to be studied will be assessed by the clinicians in the research group; studies will be postponed or cancelled if the infant is considered to be unfit to take part. 1. Infants who are asleep 2. Infants who are fed 30 minutes or less before the heel lance 3. Signs of tissue damage on the lower limbs 4. Intraventricular haemorrhage or periventricular leukomalacia 5. Infants who have had previous surgery 6. Infants who are receiving analgesics or sedatives 7. Infants who are born to mothers who are diabetic or opioid users 8. Infants born with congenital malformations or genetic conditions In addition, infants that fall into the following criteria will be excluded from the study as use of 24% sucrose water is contraindicated: 9. Infants at high risk for necrotising enterocolitis 10. Asphyxiated infants 11. Infants with feeding intolerance 12. Infants without bowel sounds 13. Infants with oesophageal atresia or tracheal oesophageal fistula 14. Infants with active phase persistent pulmonary hypertension of the newborn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cortical responses to noxious stimulation using evoked potentials (electroencephalography [EEG]) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sleep-state (EEG and video) 2. Blood glucose levels (opportunistically measured from excess blood flow) 3. Motor and facial activity (electromyogram [EMG] and video) | — |
Countries
United Kingdom
Outcome results
None listed