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Self Medication With Oral Morphine After Total Knee Arthroplasty.

This study has been completed.
Sponsor:
Collaborator:
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT01226186
First received: October 21, 2010
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Arthroplasty, Knee Replacement
Pain Control
 Behavioral: Nurse dispensed oral morphine.
Behavioral: Patient self medication of oral morphine.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self Medication With Oral Morphine After Total Knee Arthroplasty. A Randomised Controlled Trial Comparing Self Medication With Standard Nurse Dispensing. Is There a Difference in Morphine Consumption, Pain, Patient Satisfaction or Safety?

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:
  • To establish if patients who self medicate with oral morphine have differing pain levels than those who take nurse dispensed oral morphine. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 144
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nurse dispensed oral morphine solution. Behavioral: Nurse dispensed oral morphine.
Nurse will dispense oral morphine on request from the patient.
Active Comparator: Self medicated oral morphine solution. Behavioral: Patient self medication of oral morphine.
Patients will self medicate their oral morphine pain control solution following surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring total knee replacement surgery willing to provide written, informed consent.

Exclusion Criteria:

  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226186

Locations
United Kingdom
Derwent Unit, Royal Bournemouth Hospital.
Bournemouth., Dorset., United Kingdom, BH7 7DW
Sponsors and Collaborators
The Royal Bournemouth Hospital
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Jonathan Linton, Doctor Poole Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier: NCT01226186     History of Changes
Other Study ID Numbers: 10/H0505/77
Study First Received: October 21, 2010
Last Updated: December 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by The Royal Bournemouth Hospital:
Knee replacement
Pain control
Self medication

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 21, 2013