The efficacy of non-steroidal anti-inflammatory drugs and their effect on renal function in small infants following minor surgery
| ISRCTN | ISRCTN33935125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33935125 |
| Secondary identifying numbers | N0012120214 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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 H Glaisyer
Scientific
Scientific
PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
| Phone | +44 (0)20 7405 9200 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The efficacy of non steroidal anti-inflammatory drugs and their effect on renal function in small infants following minor surgery |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 10/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Infants who have undergone minor surgery |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/07/2003 |
| Date of final enrolment | 10/07/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Great Ormond Street Hospital for Children
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- GOSH
- Location
- United Kingdom
Institute of Child Health, University College London
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- UCL Great Ormond Street Institute of Child Health, GOS ICH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
