Effect of analgesia using buccal fentanyl versus diclofenac suppository for extracorporeal shock wave lithotripsy

ISRCTN ISRCTN75580529
DOI https://doi.org/10.1186/ISRCTN75580529
Secondary identifying numbers N/A
Submission date
04/04/2012
Registration date
06/11/2013
Last edited
30/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Extracorporeal shock wave lithotripsy (ESWL) is the name of the treatment that breaks down kidney stones into smaller pieces that can then be passed out in urine. The treatment can be painful. Rectal diclofenac is one of the common pain killers used for ESWL in the UK. Our goal is to find out what works better: oral diclofenac or buccal fentanyl (in the mouth). We are intending to assess the discomfort experienced by the patient before, during and after the treatment. We also intend to record any side effects and complications of analgesia used.

Who can participate?
We are intending to recruit 80-100 patients undergoing ESWL treatment in the Bedford Hospital (UK).

What does the study involve?
All the patients undergoing ESWL treatment in Bedford Hospital will be randomly allocated to one of two groups: they will either receive diclofenac suppository or buccal fentanyl as analgesia prior to the treatment. All participating patients will be asked to quantify the discomfort during, throughout and after the treatment. All side effects will be documented. Results will subsequently be compared between the two groups in the study.

What are possible benefits and risks of participating?
There will be no immediate benefit to those taking part. Following the study completion we will be able to draw conclusions whether buccal fentanyl analgesia is more efficient and safer for the patients undergoing ESWL treatment. Any potential risks are related to potential side effects of diclofenac and fentanyl. However, there is no increased risk to the patients as both oral diclofenac and buccal fentanyl are well established and widely used as analgesia is vital part of ESWL treatment.

Where is the study run from?
The study has been set up in Urology Department of Bedford Hospital NHS Trust.

When is the study starting and how long is it expected to run for?
We anticipate the study to start in July 2012 and run for 12 months or until 100 participants is recruited.

Who is funding the study?
Urology Department Bedford Hospital NHS Trust (UK)

Who is the main contact?
Mr Aasem Chaudry
aasem.chaudry@bedfordhospital.nhs.uk

Contact information

Mr Aasem Chaudry
Scientific

Bedford Hospital NHS Trust
Urology Department
Bedford
MK42 9DJ
United Kingdom

Study information

Study designRandomised single blind controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOpen-label randomised controlled study of efficacy of buccal fentanyl versus diclofenac suppository analgesia for extracorporeal shock wave lithotripsy
Study objectivesTo assess the efficacy of buccal fentanyl use as analgesia for extracorporeal shock wave lithotripsy.
Pain associated with extracorporeal shock wave lithotripsy treatment is due to repetitive shockwave applied to body surface. Various analgesic agents are used worldwide. Diclofenac is widely established. Buccal fentanyl is supposed to have a quicker mode of action due to buccal mucosal absorption and be potentially better tolerated due to lack of gastrointestinal side effects.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPain associated with extracorporeal shock wave lithotripsy treatment is due to repetitive shockwave applied to body surface.
InterventionRandomised single-blind controlled trial comparing two interventions - buccal fentanyl versus oral diclofenac analgesia for ESWL.
One group will receive 100mcg of buccal fentanyl and second group will receive 100mg of oral diclofenac.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Diclofenac, fentanyl
Primary outcome measurePain measured on Visual Analogue Scale score (0= No pain, 10=Unbearable pain)
Secondary outcome measuresPresence of adverse reactions to buccal fentanyl or oral diclofenac
Overall study start date01/08/2012
Completion date01/03/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteriaPatients undergoing extracorporeal shock wave lithotripsy in Bedford Hospital NHS Trust
Key exclusion criteria1. Patient's refusal to be included in the trial
2. Allergy or adverse reaction to fentanyl or diclifenac
3. Contraindications to fentanyl or diclofenac
Date of first enrolment01/08/2012
Date of final enrolment01/03/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom

Sponsor information

Bedford Hospital NHS Trust (UK)
Hospital/treatment centre

Kempston Road
Bedford
MK42 9DJ
England
United Kingdom

Website http://www.bedfordhospital.nhs.uk/
ROR logo "ROR" https://ror.org/031nbgr73

Funders

Funder type

Hospital/treatment centre

Bedford Hospital NHS Trust

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator