Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
25/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr L Goldsworthy

ORCID ID

Contact details

C/O Research & Effectiveness Department
Level 1
The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
r&eoffice@ubht.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264135960

Study information

Scientific title

Does glucose analgesia have a role in infants in an emergency department

Acronym

Study hypothesis

To determine whether sucrose analgesia is as adequate in infants as in neonates

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Surgery: Analgesia

Intervention

Double randomised controlled trial. Infants randomised to:
1. 50% sucrose solution
2. Placebo solution

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2003

Overall trial end date

31/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

60 infants attending the emergency department and requiring a painful procedure

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2003

Recruitment end date

31/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

United Bristol Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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