Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/12/2014
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 H Glaisyer

ORCID ID

Contact details

PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
+44 (0)20 7405 9200
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0012120214

Study information

Scientific title

The efficacy of non steroidal anti-inflammatory drugs and their effect on renal function in small infants following minor surgery

Acronym

Study hypothesis

The primary objective is to establish the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) compared with paracetamol in small infants following minor surgery.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Urological and Genital Diseases: Renal function

Intervention

Random allocation to (A) Non-steroidal anti-inflammatory drugs (B) Paracetamol.

Intervention type

Drug

Phase

Not Applicable

Drug names

Non-steroidal anti-inflammatory drugs, paracetamol

Primary outcome measures

1. Pain scores
2. Time to supplementary analgesia
3. Total supplementary analgesia
4. Changes in renal function

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/07/2003

Overall trial end date

10/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Infants who have undergone minor surgery

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/07/2003

Recruitment end date

10/07/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Great Ormond Street Hospital for Children

Alternative name(s)

GOSH

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Funder name

Institute of Child Health, University College London

Alternative name(s)

ICH

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes