Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects

Acute Pain Clinical Trial

Official title:

Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738036
• Other study ID #: 07 001 07
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: May 10, 2017
• Start date: April 2008
• Est. completion date: November 2009

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To define a rational pharmacological management of pain for the subjects under opioid maintenance therapy (methadone or buprenorphine), it is first of all necessary to estimate the efficiency of the current practices on pain management as well as their potentially noxious consequences, in particular on the long term opioid maintenance therapy.

The objective of the study is to compare the efficiency of the opioid maintenance therapy according to the arisen of an acute painful phenomenon requiring an analgesic management for these patients. At first, this work will allow to determine the results on acute pain of the current practices for these patients. The comparison of the long term consequences on opioid maintenance therapy between the patients that presented an acute painful phenomenon and the control patients should help to improve acute pain management for these patients while limiting the risk of relapse in the abused consumption of psychoactive substances.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 or more.

• Patients under opioid maintenance therapy (buprenorphine or methadone)

• Patients treated by the same drug (buprenorphine or methadone) since at least 3 months

Exclusion Criteria:

• Refusal of the patient to take part in the study

• Absence of possible follow-up

Related Conditions & MeSH terms

• Acute Pain

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Bounes V, Palmaro A, Lapeyre-Mestre M, Roussin A. Long-term consequences of acute pain for patients under methadone or buprenorphine maintenance treatment. Pain Physician. 2013 Nov-Dec;16(6):E739-47. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate under buprenorphine or methadone treatment defined as the percentage of patients still under treatment during the follow-up		1, 3, 6 and 12 months
Secondary	pain, anxiety, drugs, alcohol and other substances abuse and dependence, drug prescription (included for pain treatment and opioid maintenance)		1, 3, 6 and 12 months