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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04813458
Other study ID # 202007-00107
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date August 1, 2021

Study information

Verified date March 2021
Source Singapore General Hospital
Contact Christopher Liu
Phone +6582181062
Email christopher.liu.w.y@singhealth.com.sg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The rampant prescription of opioid has in part contributed to the ongoing worldwide opioid crisis. In the United States of America, it is estimated that death from the use of opioids outnumber death from motor vehicle accident deaths by more than 40%. Consequently, many countries such as America and Canada have drawn up guidelines pertaining to safe opioid prescribing. Tramadol is often used by pain physicians to treat chronic pain. As it is a weak opioid and unscheduled in many countries, it is often considered to have a lower addiction potential compared to strong opioids. Despite this, the literature does reveal evidence of abuse, addiction and withdrawal - although the incidence of this is unclear. In this study, the investigators aim to determine the prevalence of tramadol misuse in a pain clinic population. The investigators also aim to determine the real-life compliance of physicians to guidelines provided by International regulatory bodies (CDC) and the modifiable risk factors associated with tramadol misuse.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date August 1, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients attending pain clinic in Singapore General Hospital, Seng Kang General Hospital and Changi General Hospital Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Singapore Changi General Hospital Singapore
Singapore Seng Kang General Hospital Singapore
Singapore Singapore General Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Current Opioid Misuse Measure (COMM) The primary outcome is the prevalence of Current Opioid Misuse (defined as a COMM score of 9 or greater) in the patients included in the cross-sectional study (ie patients who are on tramadol) Baseline
Secondary Patient Health Questionnaire-9 (PHQ-9) PHQ-9 measures depression with scores of 5-9, 10-14,15-19 and 20 or higher representing mild, moderate , moderate to severe and severe depression. PHQ-9 scores will be performed on all patients to determine the level of depression among patients prescribed tramadol. Baseline
Secondary General Anxiety Disorder-7 (GAD-7) GAD-7 measures anxiety with scores of 5, 10 and 15 representing mild, moderate and severe anxiety. GAD-7 scores will be performed on all patients to determine the level of anxiety among patients prescribed tramadol. Baseline
Secondary Opioid Risk Tool (ORT) ORT measures the risk of future opioid abuse. A score of equal or less than 3 correlates with a low risk of opioid abuse. Scores of 4 to 7 indicates moderate risk and scores above 8 represents high risk.ORT scores will be performed on all patients to determine the risk of future opioid misuse among patients prescribed tramadol. Baseline
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