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.
Conditions
Interventions
Product Name: Oral transmucosal fentanyl
Product Code: Actiq
Pharmaceutical Form: Lozenge
INN or Proposed INN: Oral transmucosal fentanyl citrate
Sponsors
Aintree University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether oral transmucosal fentanyl effective at relieving pain during retinal photocoagulation to treat proliferative diabetic retinopathy, compared to placebo. ; 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. 2. To determine the acceptability of the intervention with regards minor side effects ; Primary end point(s): 1. A completed visual analogue pain score for each patient (n = 38), for each laser treatment session. 2. A completed side effect questionnaire for each patient (n = 38), for each laser treatment session. 3. Calculation of the mean and standard deviation of outcome measurements. | — |
Countries
United Kingdom
Outcome results
None listed