A randomised cross-over pilot study of Entonox for pain relief in ophthalmic laser
| ISRCTN | ISRCTN02817810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02817810 |
| Protocol serial number | N0207073131 |
| Sponsor | Department of Health |
| Funder | Royal Liverpool and Broadgreen University Hospitals Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 10/12/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Simon Harding
Scientific
Scientific
St Pauls Eye Unit
2Z Link
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
| Phone | +44 (0)151 706 3971 |
|---|---|
| l.gee@liv.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised cross-over pilot study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | Entomox for pain relief in ophthalmic laser Added 10/12/09: trial stopped due to lack of funding/sponsorship and participant recruitment issue |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Entonox |
| Primary outcome measure(s) |
Pain score assessment after each treatment |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2004 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship + Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | Patients attending for a course of laser pan-retinal photocoagulation will undergo a standardised treatment, receiving entonox on alternative visits. A pain score will be assessed after each treatment. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2000 |
| Date of final enrolment | 30/06/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Pauls Eye Unit
Liverpool
L7 8XP
United Kingdom
L7 8XP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
