ISRCTN ISRCTN22864818
DOI https://doi.org/10.1186/ISRCTN22864818
Protocol serial number N0264135960
Sponsor Department of Health
Funder United Bristol Healthcare NHS Trust (UK)
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
29/03/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L Goldsworthy
Scientific

C/O Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom

Phone +44 (0)117 928 3473
Email r&eoffice@ubht.swest.nhs.uk

Study information

Primary study designInterventional
Study designRandomised placebo controlled parallel group trial
Secondary study designRandomised controlled trial
Scientific titleDoes glucose analgesia have a role in infants in an emergency department
Study objectivesTo determine whether sucrose analgesia is as adequate in infants as in neonates
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Analgesia
InterventionDouble randomised controlled trial. Infants randomised to:
1. 50% sucrose solution
2. Placebo solution
Intervention typeProcedure/Surgery
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/05/2004

Eligibility

Participant type(s)Patient
Age groupChild
SexAll
Target sample size at registration60
Key inclusion criteria60 infants attending the emergency department and requiring a painful procedure
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/10/2003
Date of final enrolment31/05/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

29/03/2018: No publications found, verifying study status with principal investigator.
25/02/2016: Internal review
11/02/2016: No publications found, verifying study status with principal investigator