Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Non-steroidal anti-inflammatory drugs, paracetamol
Primary outcome measure
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 study start date
10/07/2003
Overall study end date
10/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Infants who have undergone minor surgery
Participant type(s)
Patient
Age group
Child
Sex
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
England, United Kingdom
Study 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
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
Local government
Location
United Kingdom
Funder name
Institute of Child Health, University College London
Alternative name(s)
UCL Great Ormond Street Institute of Child Health, GOS ICH
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|