The efficacy of oral transmucosal fentanyl as an analgesic agent during pan retinal photocoagulation (Pilot Study) - Transmucosal fentanyl analgesia in retinal photocoagulatio
Phase 1
- Conditions
- Diabetic retinopathy - the commonest cause of blindness in the working age group in the United Kingdom. Retinal photocoagulation is a painful procedure, which forms the mainstay of treatment of diabetic retinopathy.
- Registration Number
- EUCTR2006-000082-10-GB
- Lead Sponsor
- Aintree University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 38
Inclusion Criteria
Consecutive adult patients undergoing PRP for ANY reason
- pan retinal / sectoral
- one / both eyes
Previous laser treatment to the same eye is NOT an exclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Morphine / codeine allergy
Mental incapability to provide informed consent
Concomitant or recent (within 2 weeks) use of monoamine oxidase inhibitors (MAOIs)
Age < 18 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether oral transmucosal fentanyl effective at relieving pain during retinal photocoagulation to treat proliferative diabetic retinopathy, compared to placebo. ;<br> Secondary Objective: 1. To determine the mean and standard deviation of outcome measurements, to allow sample size calculation before undertaking a larger randomised control trial.<br><br> 2. To determine the acceptability of the intervention with regards minor side effects<br> ;<br> Primary end point(s): 1. A completed visual analogue pain score for each patient (n = 38), for each laser treatment session.<br> 2. A completed side effect questionnaire for each patient (n = 38), for each laser treatment session.<br> 3. Calculation of the mean and standard deviation of outcome measurements.<br>
- Secondary Outcome Measures
Name Time Method