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 |
| Protocol serial number | N/A |
| Sponsor | Central Manchester Foundation Trust (CMFT) (UK) |
| Funder | TherabelPharma NV (Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Open-label single-dose pharmacokinetic trial |
| Secondary study design | Non randomised study |
| Study type | Participant 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 |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Diclofenac |
| Primary outcome measure(s) |
Plasma diclofenac assays |
| Key secondary outcome measure(s) |
Measuring decaying plasma concentrations to estimate ancillary parameters such as Cmax, Tmax, UAC and T1/2 |
| 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 | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal Manchester Children's Hospital
Manchetser
M13 9WL
United Kingdom
M13 9WL
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/06/2017: The trial was stopped as the product under investigation was withdrawn from the UK market on 21/05/2010.
