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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19696704
Publication citations
-
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.