Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Open-label randomised controlled study of efficacy of buccal fentanyl versus diclofenac suppository analgesia for extracorporeal shock wave lithotripsy
Acronym
Study hypothesis
To 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
Not provided at time of registration
Study design
Randomised single blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pain associated with extracorporeal shock wave lithotripsy treatment is due to repetitive shockwave applied to body surface.
Intervention
Randomised 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 type
Drug
Phase
Not Applicable
Drug names
Diclofenac, fentanyl
Primary outcome measure
Pain measured on Visual Analogue Scale score (0= No pain, 10=Unbearable pain)
Secondary outcome measures
Presence of adverse reactions to buccal fentanyl or oral diclofenac
Overall trial start date
01/08/2012
Overall trial end date
01/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing extracorporeal shock wave lithotripsy in Bedford Hospital NHS Trust
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patient's refusal to be included in the trial
2. Allergy or adverse reaction to fentanyl or diclifenac
3. Contraindications to fentanyl or diclofenac
Recruitment start date
01/08/2012
Recruitment end date
01/03/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom
Sponsor information
Organisation
Bedford Hospital NHS Trust (UK)
Sponsor details
Kempston Road
Bedford
MK42 9DJ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Bedford Hospital NHS Trust
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
Basic results (scientific)
Publication list