Condition category
Surgery
Date applied
23/02/2010
Date assigned
07/04/2010
Last edited
30/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dylan Prosser

ORCID ID

Contact details

Department of Paediatric Anaesthesia
Royal Manchetser 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

Cohort study

Trial setting

Hospitals

Trial type

Other

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 (Dyloject®)

Primary outcome measures

Plasma diclofenac assays

Secondary outcome measures

Measuring decaying plasma concentrations will allow us 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

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

Department of Paediatric Anaesthesia
Manchetser
M13 9WL
United Kingdom

Sponsor information

Organisation

Central Manchester Foundation Trust (CMFT) (UK)

Sponsor details

CMFT Headquarters
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes