Contact information
Type
Scientific
Primary contact
Dr Dylan Prosser
ORCID ID
Contact details
Department of Paediatric Anaesthesia
Royal Manchester Children's Hospital
Oxford Road
Manchetser
M13 9WL
United Kingdom
+44 (0)1617011263
dylan.prosser@cmft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A pharmacokinetic study of intravenous diclofenac (Dyloject®) in children undergoing routine surgery: an open-label, single-dose trial
Acronym
Study hypothesis
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
Pan-Manchester R&D committee - approval pending
Study design
Open-label single-dose pharmacokinetic trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet.
Condition
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 names
Diclofenac
Primary outcome measures
Plasma diclofenac assays
Secondary outcome measures
Measuring decaying plasma concentrations to estimate ancillary parameters such as Cmax, Tmax, UAC and T1/2
Overall trial start date
01/06/2010
Overall trial end date
01/06/2011
Reason abandoned
Objectives no longer viable
Eligibility
Participant inclusion criteria
Children aged 2 to 8 years undergoing routine surgery including ear, nose and throat (ENT), orthopaedic, urological and general
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
25
Participant 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
Recruitment start date
01/06/2010
Recruitment end date
01/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Manchester Children's Hospital
Manchetser
M13 9WL
United Kingdom
Funders
Funder type
Industry
Funder name
TherabelPharma NV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary