Self Medication With Oral Morphine After Total Knee Arthroplasty.
1 other identifier
interventional
144
1 country
1
Brief Summary
The study aims to compare two post operative pain management strategy's, traditional nurse dispensed pain control versus patient self medication. The investigators aim to establish if patients who self medicate have differing pain levels than those who take nurse dispensed oral morphine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 21, 2010
CompletedFirst Posted
Study publicly available on registry
October 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 4, 2012
December 1, 2012
8 months
October 21, 2010
December 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To establish if patients who self medicate with oral morphine have differing pain levels than those who take nurse dispensed oral morphine.
one year
Secondary Outcomes (2)
To identify if patients who self medicate with oral morphine take a significantly different amount of morphine compared with those who take nurse dispensed oral morphine.
one year
To compare whether patients who self medicate with oral morphine have a significantly altered level of side effects compared with those who take nurse dispensed oral morphine.
one year
Study Arms (2)
Nurse dispensed oral morphine solution.
ACTIVE COMPARATORSelf medicated oral morphine solution.
ACTIVE COMPARATORInterventions
Nurse will dispense oral morphine on request from the patient.
Patients will self medicate their oral morphine pain control solution following surgery.
Eligibility Criteria
You may qualify if:
- Patients requiring total knee replacement surgery willing to provide written, informed consent.
You may not qualify if:
- Unable to safely self medicate.
- Allergy to morphine.
- Unable to provide consent.
- Contraindication to the standardised anaesthetic or standard postoperative care.
- Not consenting to an element of the standardised anaesthetic.
- Pre-operative use of strong opiates e.g. Oramorph, MST, Oxynorm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Derwent Unit, Royal Bournemouth Hospital.
Bournemouth, Dorset., BH7 7DW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Linton, Doctor
Poole Hospital NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2010
First Posted
October 22, 2010
Study Start
October 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
December 4, 2012
Record last verified: 2012-12