Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/10/2011
Prospective/Retrospective
Retrospectively 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

Mr David Ian Clark

ORCID ID

Contact details

Ophthalmology
Walton Hospital
Rice Lane
Liverpool
L9 1AE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025180535

Study information

Scientific title

Acronym

Study hypothesis

Study hypothesis amended as of 09/05/2008:
Diabetic retinopathy is the commonest cause of blindness and visual impairment in the working age group in the United Kingdom. Argon laser peripheral retinal scatter photocoagulation (PRP) is a commonly performed ophthalmic procedure which is used to treat diabetic retinopathy and other retinal vascular disease. It forms the mainstay of treatment of proliferative diabetic retinopathy, and is supported by a large evidence base.

Aims:
1. To evaluate the analgesic effect of oral transmucosal fentanyl citrate (OTFC) during pan retinal
photocoagulation (PRP), compared with placebo
2. To determine the side effect profile of OTFC in opiate naive patients undergoing PRP

Study aim provided at time of registration:
To determine whether oral transmucosal fentanyl provides effective pain relief during peripheral retinal laser photocoagulation.

Ethics approval

Sefton Local Research Ethics Committee. Date of approval: 190/06/2006 (ref: 06/Q1501/64-3)

Study design

Prospective, randomised, double-masked, crossover, pilot, single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Diabetic retinopathy

Intervention

Please note that, as of 09/05/2008, the start and anticipated end dates of this trial were updated from 01/05/2006 and 01/08/2007 to 01/09/2006 and 01/12/2007, respectively.

Interventions amended as of 09/05/2008:
Patients will be divided into two groups. Stratified randomisation into two groups of 19 will be generated by a using a random number table. Randomisation will be concealed by the pharmacy department until the trial is complete. The medication will be stored in the hospital pharmacy, and collected and signed for by nursing staff on a patient by patient basis.

Each patient will receive appropriate laser treatment divided equally over two separate visits (approximately 1,500 burns per visit). At each visit, each patient will be given a lollipop to suck for 30 minutes prior to commencement of laser treatment. The contents of the lollipop will be double-masked. Patients in one group will receive the placebo lollipop at the first visit and the treatment lollipop containing transmucosal fentanyl (200 mcg) at the second visit. Patients in the second group will receive the treatment lollipop at the first visit and placebo at the second (cross-over). The two visits will be 1 week apart.
Following each treatment, the patient will complete a visual analogue pain score and side effect questionnaire relating to that visit.

Interventions provided at time of registration:
Prospective randomised double-masked crossover pilot trial comparing oral transmucosal fentanyl 200 mcg vs placebo. Patients divided into 2 groups. Stratified randomisation into 2 groups of 19 using random number table. All patients receive laser treatment appropriate to clinical needs, and complete pre-study questionnaire. At each of 2 visits patients will be given a lollipop to suck for 30 minutes prior to laser treatment, the content of the lollipop will be masked. Following each treatment the patient will complete a visual analogue pain score and side effect questionnaire.

Intervention type

Drug

Phase

Not Specified

Drug names

transmucosal fentamyl

Primary outcome measures

Added as of 09/05/2008:
1. Visual analogue pain score (100 mm) for each patient, after each laser treatment session
2. Side effect questionnaire for each patient, after each laser treatment session

Secondary outcome measures

Added as of 09/05/2008:
1. Calculation of the mean and standard deviation of outcome measurements

Overall trial start date

01/09/2006

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Added as of 09/05/2008:
1. Both males and females
2. Patients undergoing pan retinal photocoagulation (PRP) for any reason:
2.1. Pan retinal/ sectoral
2.2. One/ both eyes

NB: Previous laser treatment to the same eye is not an exclusion criteria

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

38

Participant exclusion criteria

Added as of 09/05/2008:
1. Age <18 years
2. Morphine/ codeine allergy
3. Chronic obstructive pulmonary disease/ emphysema
4. Mental incapability to provide informed consent
5. Concomitant or recent (within 2 weeks) use of monoamine oxidase inhibitors (MAOIs)

Recruitment start date

01/09/2006

Recruitment end date

01/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ophthalmology
Liverpool
L9 1AE
United Kingdom

Sponsor information

Organisation

Aintree University Hospitals NHS Foundation Trust (UK)

Sponsor details

Research and Development Directorate
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom

Sponsor type

Government

Website

http://www.aintreehospitals.nhs.uk

Funders

Funder type

Government

Funder name

a. Aintree University Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

b. Cephalon Ltd (UK), providing transmucosal fentanyl citrate and placebo lozenges

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

c. NHS R&D Support Funding (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19696704

Publication citations

  1. Results

    Hillier RJ, Aboud A, Thind G, Clark DI, Oral transmucosal fentanyl citrate: a novel analgesic agent for use in retinal photocoagulation., Retina (Philadelphia, Pa.), 29, 10, 1506-1512, doi: 10.1097/IAE.0b013e3181ae70d4.

Additional files

Editorial Notes