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Register:	ISRCTN
Last refreshed on:	26 February 2018
Main ID:	ISRCTN90932532
Date of registration:	12/09/2003
Prospective Registration:	No
Primary sponsor:	Department of Health (UK)
Public title:	A prospective study to compare the effectiveness of giving normal release morphine sulphate overnight on a regular 4 hourly basis or on an 'as required basis' in patients with cancer
Scientific title:	A prospective study to compare the effectiveness of giving normal release morphine sulphate overnight on a regular 4 hourly basis or on an 'as required basis' in patients with cancer
Date of first enrolment:	01/09/2001
Target sample size:	85
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN90932532
Study type:	Interventional
Study design:	Randomised controlled trial (Not Specified)
Phase:	Not Applicable

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Janet Hardy
Address:	c/o Palliative Care Mater Adult Hospital Raymond Terrace Qld 4101 South Brisbane Australia
Telephone:	+61 7 3163 8630
Email:	janet.hardy@mater.org.au
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Multicentre 85 patients.
Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Cancer: Pain management
Cancer
Malignant neoplasm without specification of site

Intervention(s)

Randomised test intervention versus standardised intervention, non-blinded (Phase 3).
Group A: On days 1 and 2, patients will be given 4 hourly morphine during the day and at 23.00 h, 03.00 h and 07.00 h at night. On days 3 and 4, patients will be given 4 hourly morphine during the day and a single dose of morphine at 23.00 h and a single 4 hourly dose at 07.00 h (ie omitting the 03.00 h dose)
Group B: On days 1 and 2, patients will be given 4 hourly morphine during the day and a single dose of morphine at 23.00 h and a single 4 hourly dose at 07.00 h (ie omitting the 03.00 h dose). On days 3 and 4, patients will be given 4 hourly morphine during the day and at 23.00 h, 03,00 h and 07.00 h at night.
In both Groups: all patients have the option of requesting a breakthrough dose of morphine at any time, equivalent to a single 4 hourly dose.

Primary Outcome(s)

To provide an evidence base for overnight administration regimes for patients receiving normal release morphine for cancer pain.

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

N0258107458

Source(s) of Monetary Support

The Royal Marsden NHS Foundation Trust (UK)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

Results available:	Yes
Date Posted:
Date Completed:	01/08/2003
URL:

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