| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN27801757 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0025180535 |
| Public title | The efficacy of oral transmucosal fentamyl as an analgesic agent during pan retinal photocoagulation |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Eye Diseases: Retinal diseases |
| Study hypothesis | To determine whether oral transmucosal fentanyl provides effective pain relief during peripheral retinal laser photocoagulation. |
| Design/methodology | Prospective randomised double-masked crossover pilot trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Not provided at time of registration |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 01/05/2006 |
| Anticipated end date | 01/08/2007 |
| Status of trial | Completed |
| Target number of participants | 38 |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Aintree Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr David Ian Clark |
| Contact details | Ophthalmology
Walton Hospital
Rice Lane
Liverpool
United Kingdom
L9 1AE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN27801757 |
| Date last extracted from ISRCTN register | 17/04/2008 |
