A clinical study investigating sucrose as a pain reliever in infants
| ISRCTN | ISRCTN78390996 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78390996 |
| Secondary identifying numbers | 08/0213 |
- Submission date
- 20/03/2009
- Registration date
- 30/07/2009
- Last edited
- 10/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Judith Meek
Scientific
Scientific
Elizabeth Garrett Anderson Wing
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
Study information
| Study design | Double-blind randomised controlled single centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A double‐blinded randomised controlled study to assess the effect of sucrose versus sterile water on cortical responses to painful events in newborn infants |
| Study objectives | This is a non-commercial, double-blinded randomised controlled clinical study. The primary objective is to investigate the effects of sucrose versus control (sterile water) on cortical responses to noxious events in newborn infants. The secondary objectives are to examine if sucrose administration will: 1. Induce a change of sleep state 2. Affect an immediate detectable change in blood glucose levels 3. Affect motor activity reflex responses following a noxious event, when compared to control (sterile water) treated groups. This trial is taking place at the University College London Hospital. |
| Ethics approval(s) | The Joint UCL/UCLH Committees on the Ethics of Human Research Committee Alpha, approved on 30th September 2008 (ref: 08/H0715/74) |
| Health condition(s) or problem(s) studied | Pain relief following an acute noxious event in newborn infants |
| Intervention | 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% chance of receiving sucrose. The treatment solution will be administered by a syringe directly into the baby's mouth approximately 2 minutes prior to the heel lance. The sucrose and placebo will be purchased from Inspiration Healthcare, the manufacturers of Sweet-Ease®. Each recruited subject will participate in a single study and will not require a follow-up. The duration of total participation in the study will take approximately 90 minutes. Please note that as of 11/02/10 the end date of this trial has been extended from 31/12/09 to 31/12/2010. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sucrose |
| Primary outcome measure | Cortical responses to noxious stimulation using evoked potentials (electroencephalography [EEG]) |
| Secondary outcome measures | 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) |
| Overall study start date | 25/02/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 60 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 25/02/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Elizabeth Garrett Anderson Wing
London
NW1 2BU
United Kingdom
NW1 2BU
United Kingdom
Sponsor information
University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
250 Euston Road
London
NW1 2PG
England
United Kingdom
| Website | http://www.uclh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/042fqyp44 |
Funders
Funder type
Government
Medical Research Council (MRC) (UK) (ref: G0502146)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/10/2010 | Yes | No |
