Condition category
Signs and Symptoms
Date applied
04/04/2012
Date assigned
06/11/2013
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Aasem Chaudry

ORCID ID

Contact details

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

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 measures

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

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

http://www.bedfordhospital.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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