Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
08/0213
Study information
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
Acronym
Study hypothesis
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
The Joint UCL/UCLH Committees on the Ethics of Human Research Committee Alpha, approved on 30th September 2008 (ref: 08/H0715/74)
Study design
Double-blind randomised controlled single centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
25/02/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
25/02/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Elizabeth Garrett Anderson Wing
London
NW1 2BU
United Kingdom
Sponsor information
Organisation
University College London Hospitals NHS Foundation Trust (UK)
Sponsor details
250 Euston Road
London
NW1 2PG
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Medical Research Council (MRC) (UK) (ref: G0502146)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20817247
Publication citations
-
Results
Slater R, Cornelissen L, Fabrizi L, Patten D, Yoxen J, Worley A, Boyd S, Meek J, Fitzgerald M, Oral sucrose as an analgesic drug for procedural pain in newborn infants: a randomised controlled trial., Lancet, 2010, 376, 9748, 1225-1232, doi: 10.1016/S0140-6736(10)61303-7.