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

Elizabeth Garrett Anderson Wing
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom

Study information

Study designDouble-blind randomised controlled single centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA double‐blinded randomised controlled study to assess the effect of sucrose versus sterile water on cortical responses to painful events in newborn infants
Study objectivesThis 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) studiedPain relief following an acute noxious event in newborn infants
InterventionSubjects 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Sucrose
Primary outcome measureCortical responses to noxious stimulation using evoked potentials (electroencephalography [EEG])
Secondary outcome measures1. 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 date25/02/2009
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants60
Key inclusion criteria1. 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 criteriaPrior 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 enrolment25/02/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Elizabeth Garrett Anderson Wing
London
NW1 2BU
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

250 Euston Road
London
NW1 2PG
England
United Kingdom

Website http://www.uclh.nhs.uk/
ROR logo "ROR" https://ror.org/042fqyp44

Funders

Funder type

Government

Medical Research Council (MRC) (UK) (ref: G0502146)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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