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 |
| Protocol serial number | N0012120214 |
| Sponsor | Department of Health (UK) |
| Funders | Great Ormond Street Hospital for Children, Institute of Child Health, University College London |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Non-steroidal anti-inflammatory drugs, paracetamol |
| Primary outcome measure(s) |
1. Pain scores |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
