The efficacy of oral transmucosal fentamyl as an analgesic agent during pan retinal photocoagulation

ISRCTN ISRCTN27801757
DOI https://doi.org/10.1186/ISRCTN27801757
Secondary identifying numbers N0025180535
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
18/10/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr David Ian Clark
Scientific

Ophthalmology
Walton Hospital
Rice Lane
Liverpool
L9 1AE
United Kingdom

Study information

Study designProspective, randomised, double-masked, crossover, pilot, single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesStudy 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(s)Sefton Local Research Ethics Committee. Date of approval: 190/06/2006 (ref: 06/Q1501/64-3)
Health condition(s) or problem(s) studiedDiabetic retinopathy
InterventionPlease 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)transmucosal fentamyl
Primary outcome measureAdded 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 measuresAdded as of 09/05/2008:
1. Calculation of the mean and standard deviation of outcome measurements
Overall study start date01/09/2006
Completion date01/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants38
Key inclusion criteriaAdded 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
Key exclusion criteriaAdded 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)
Date of first enrolment01/09/2006
Date of final enrolment01/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Ophthalmology
Liverpool
L9 1AE
United Kingdom

Sponsor information

Aintree University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

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

Website http://www.aintreehospitals.nhs.uk
ROR logo "ROR" https://ror.org/02h67vt10

Funders

Funder type

Government

a. Aintree University Hospitals NHS Foundation Trust (UK)

No information available

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

No information available

c. NHS R&D Support Funding (UK)

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2009 Yes No