Self Medication With Oral Morphine After Total Knee Arthroplasty.

Pain Control Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226186
• Other study ID #: 10/H0505/77
• Status: Completed
• Phase: N/A
• First received: October 21, 2010
• Last updated: December 3, 2012
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2012
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Knee Replacement
• Pain Control

Intervention

Behavioral:
• Nurse dispensed oral morphine.
Nurse will dispense oral morphine on request from the patient.
• Patient self medication of oral morphine.
Patients will self medicate their oral morphine pain control solution following surgery.

Locations

Country	Name	City	State
United Kingdom	Derwent Unit, Royal Bournemouth Hospital.	Bournemouth.	Dorset.

Sponsors (2)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital	Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish if patients who self medicate with oral morphine have differing pain levels than those who take nurse dispensed oral morphine.		one year	No
Secondary	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	Yes
Secondary	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	Yes