Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
10/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Simon Harding

ORCID ID

Contact details

St Pauls Eye Unit
2Z Link
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
+44 (0)151 706 3971
l.gee@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0207073131

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised cross-over pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

Entonox

Primary outcome measures

Pain score assessment after each treatment

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2000

Overall trial end date

30/06/2004

Reason abandoned

Lack of funding/sponsorship + Participant recruitment issue

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2000

Recruitment end date

30/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Pauls Eye Unit
Liverpool
L7 8XP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Royal Liverpool and Broadgreen University Hospitals Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes