Does oral diclofenac together with oral paracetamol affect gastric volumes and pH in children?
| ISRCTN | ISRCTN40177280 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40177280 |
| Secondary identifying numbers | N0205128931 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 07/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 S Bhatia
Scientific
Scientific
Anaesthetic Dept
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Study information
| Study design | Randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Does oral diclofenac together with oral paracetamol affect gastric volumes and pH in children? |
| Study objectives | Does diclofenac/paracetamol given orally pre-operatively together increase gastric contents when compared to paracetamol? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Pre-operative care |
| Intervention | Diclofenac and paracetamol compared to paracetamol alone |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Diclofenac, paracetamol |
| Primary outcome measure | Volume and pH of gastric contents at induction |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 20/04/2003 |
| Completion date | 20/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. 50 children recruited from Royal London Hospital paediatric wards, aged 2-15 years 2. Elective surgery 3. American Society of Anesthesiologists (ASA) I/II |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 20/04/2003 |
| Date of final enrolment | 20/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal London Hospital
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Barts and The London NHS Trust (UK)
No information available
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 |
