QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication
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Purpose
QTc:
Since the reports of three deaths attributed to Torsade de Point (TdP) related to treatment with the long-acting methadone derivative levomethadyl acetate HCl (LAAM), methadone has been scrutinized for any possible association with TdP. Since then, several studies among Methadone Maintenance Treatment (MMT) patients and chronic pain patients were done, reporting diverse results about possible association between methadone dose and QTc prolongation. Most studies however were cross-sectional and generally found insignificant clinical prolongation of QTc. A follow up studies are of importance, and although few studies have started evaluating QTc among MMT patients, none was done among chronic pain patients with no history of drug usage. One study of 8 chronic pain patients experiencing insufficient pain control or intolerable side effects during treatment with oral morphine switched to oral methadone showed insignificant modest increase QTc following 9 month.
Perceived Sleep:
Chronic pain patients as well as drug addicts are known to suffer from poor sleep. Some studies found possible relation to methadone dose, however, no causal association was found and importantly some also found association with duration of opiate usage before starting methadone when entry to MMT clinic. Thus, patients with no history of opiate addiction are an important interesting group that may help understand relation between methadone usage and sleep quality. However, sleep must be evaluate before opiate administration and a follow up study is needed
| Condition | Intervention |
|---|---|
|
Chronic Pain |
Drug: Methadone |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication |
- To evaluate the influence of opioid drugs on QTc interval before and during Opioid treatment among patients suffering from chronic pain. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To evaluate the perceived sleep in the chronic pain patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Methadone
ECG (QT, QTc, Heart rate), Urine sample (opiates, benzodiazepines, THC, cocaine, amphetamines, methadone-metabolite), Questionnaire PSQI - perceived sleep - self report , Pain indices (severity, duration, cause, etc.) , usage of other medication for pain and other significant disease/disorders, history of drug abuse, age, sex, place of birth and ethnic origin, comorbidity. Follow up after 4weeks, 6months and 1 year will be done.Patients who start with any opiate and then switch to methadone, move to methadone follow up
|
Drug: Methadone
ECG (QT, QTc, Heart rate), Urine sample (opiates, benzodiazepines, THC, cocaine, amphetamines, methadone-metabolite), Questionnaire PSQI - perceived sleep - self report , Pain indices (severity, duration, cause, etc.) , usage of other medication for pain and other significant disease/disorders, history of drug abuse, age, sex, place of birth and ethnic origin, comorbidity. Follow up after 4weeks, 6months and 1 year will be done. Patients who start with any opiate and then switch to methadone, move to methadone follow up
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adults (18+ years) patients with chronic pain, who intend to be medicated with any opiates
Exclusion Criteria:
- patient with no opiate usage through last year
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Tel-Aviv Sourasky Medical Center, Pain Medicine Unit |
| ClinicalTrials.gov Identifier: | NCT00999440 History of Changes |
| Other Study ID Numbers: | TASMC-09-SB-0104-09-CTIL |
| Study First Received: | October 20, 2009 |
| Last Updated: | January 20, 2010 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Chronic Pain Methadone Perceived Sleep QTc |
Additional relevant MeSH terms:
|
Methadone 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 Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 22, 2013