Measurement of the blood levels of the painkiller diclofenac in children following a single intravenous dose
| ISRCTN | ISRCTN65890744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65890744 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/02/2010
- Registration date
- 07/04/2010
- Last edited
- 29/06/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 Dylan Prosser
Scientific
Scientific
Department of Paediatric Anaesthesia
Royal Manchester Children's Hospital
Oxford Road
Manchetser
M13 9WL
United Kingdom
| Phone | +44 (0)1617011263 |
|---|---|
| dylan.prosser@cmft.nhs.uk |
Study information
| Study design | Open-label single-dose pharmacokinetic trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet. |
| Scientific title | A pharmacokinetic study of intravenous diclofenac (Dyloject®) in children undergoing routine surgery: an open-label, single-dose trial |
| Study objectives | To evaluate the standard pharmacokinetic parameters such as clearance and volume of distribution of Dyloject® when administered as a single intravenous bolus dose of 0.5 mg/kg. |
| Ethics approval(s) | Pan-Manchester R&D committee - approval pending |
| Health condition(s) or problem(s) studied | Pharmacokinetic study in children |
| Intervention | Children will be starved according to the UK National Paediatric Starvation Guideline produced by the Association of Paediatric Anaesthetists of GB & Ireland in conjunction with The Royal College of Nursing. The guideline stipulates 2 hours for clear fluids and six hours for solids/food. 25 healthy children aged 2 to 8 years undergoing elective surgery will receive a single intravenous dose of diclofenac (trade name Dyloject®) 0.5 mg/kg on induction of anaesthesia. Seven 1.5 ml blood samples will be collected from each child at 2, 5, 15, 60, 120, 240 and 360 minutes after the administration of the drug through a dedicated intravenous cannula. Routine postoperative observations of temperature, pulse, blood pressure and oxygen saturation will be performed during the study period of 6 hours and beyond that as indicated by the type of surgery and postoperative care required. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Diclofenac |
| Primary outcome measure | Plasma diclofenac assays |
| Secondary outcome measures | Measuring decaying plasma concentrations to estimate ancillary parameters such as Cmax, Tmax, UAC and T1/2 |
| Overall study start date | 01/06/2010 |
| Completion date | 01/06/2011 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | Children aged 2 to 8 years undergoing routine surgery including ear, nose and throat (ENT), orthopaedic, urological and general |
| Key exclusion criteria | 1. Previous allergic reaction to nonsteriodal anti-inflammatory drugs (NSAIDs) 2. Known bleeding tendency 3. Administration of a NSAID within the past 24 hours 4. History of liver disease, abnormal renal function and gastrointestinal bleeding 5. Children with special needs in view of consent issues |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 01/06/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Manchester Children's Hospital
Manchetser
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Sponsor information
Central Manchester Foundation Trust (CMFT) (UK)
Hospital/treatment centre
Hospital/treatment centre
CMFT Headquarters
Oxford Road
Manchester
M13 9WL
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Industry
TherabelPharma NV (Netherlands)
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 |
Editorial Notes
29/06/2017: The trial was stopped as the product under investigation was withdrawn from the UK market on 21/05/2010.
