A randomised cross-over pilot study of Entonox for pain relief in ophthalmic laser

ISRCTN ISRCTN02817810
DOI https://doi.org/10.1186/ISRCTN02817810
Secondary identifying numbers N0207073131
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

St Pauls Eye Unit
2Z Link
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Phone +44 (0)151 706 3971
Email l.gee@liv.ac.uk

Study information

Study designRandomised cross-over pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Pain
InterventionEntomox for pain relief in ophthalmic laser

Added 10/12/09: trial stopped due to lack of funding/sponsorship and participant recruitment issue
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Entonox
Primary outcome measurePain score assessment after each treatment
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2000
Completion date30/06/2004
Reason abandoned (if study stopped)Lack of funding/sponsorship + Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 patients
Key inclusion criteriaPatients 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 criteriaNot provided at time of registration
Date of first enrolment01/05/2000
Date of final enrolment30/06/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St Pauls Eye Unit
Liverpool
L7 8XP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Liverpool and Broadgreen University Hospitals Trust (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