Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02799004
Other study ID # 2016-1271
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 7, 2016
Est. completion date September 30, 2018

Study information

Verified date May 2019
Source Hopital du Sacre-Coeur de Montreal
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pain is one of the most common complaints in emergency department (ED) and is still often poorly managed. A major prospective multicenter study reported that 74% of patients that had a pain complaint at ED triage are discharged in moderate to severe pain. Accordingly, physicians frequently prescribed analgesic after discharged for these patients, and opioid is given in 29% of ED visits involving pain complaints. However, few studies evaluate pain management after ED discharge: the frequency and length of opioids prescriptions, the opioids quantity taken by the patients, are the patients relieved and satisfied by these pain treatments, what are the adverse effects associated with the use of these medications, and what are the chances of developing addiction?

The primary aim of this study is to determine the required minimal opioids prescription for patients treated for acute pain after being discharge from the ED. Secondary objectives include: 1) monitor the patients' adverse events during opioids treatment; 2) evaluate the patients' level of pain relief associated with their respective opioids treatment; 3) determine the patients' level of addiction following post-ED opioids treatments.

The design of the project is a prospective observational cohort study. A cohort of consecutive ED patients aged 18 or more with an initial pain at triage of 4 or more and discharged from the ED in less than 48 hours with a prescription of opioid will be asked to participate in the study. Patients will be excluded if there is ongoing treatment for a pre-existing chronic pain condition or if they used opioid drugs in the past year. Research nurses will contact the patients by phone at three follow-up time points (1 week, 1 month, and 3 months). Follow-up phone interviews will evaluate pain intensity as well as pain treatment satisfaction (0-10 NRS), monitor adverse events, and investigate possible opioids addiction (SOWS: subjective opioid withdrawal scale). During these interviews, the nurses will also question the patients about their daily opioids usage and if they were relieved from pain.

This study will provide the base for future guidelines regarding the prescription of opioids treatment for specific pathology encountered in ED. It will also give indications on how to adjust the treatments according to adverse events and the level of addiction experienced by patients.


Recruitment information / eligibility

Status Completed
Enrollment 761
Est. completion date September 30, 2018
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years and older

- Pain level at 4 or greater at triage

- Acute pain (2 weeks or less)

- Opioids prescription at discharge

Exclusion Criteria:

- Language barrier

- Pregnancy

- Treated for chronic pain

- Hospital stay greater than 48 hours

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Hopital du Sacre-Coeur de Montreal Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioids consumption The number of opioids taken after ED discharge for a given pathology 2 weeks
Secondary Side effects Recorded undesirable side effect associated with post-emergency opioids treatment 2 weeks
Secondary Pain relief Patients' pain relief associated with a given prescription for a specific pathology 2 weeks
Secondary Addiction Patients opioids addiction at three month following a post-emergency prescription 3 months
See also
  Status Clinical Trial Phase
Completed NCT04484610 - Appropriate Opioid Quantities for Acute Pain - Pharmacist Study Phase 4
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT03825549 - A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing N/A
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Recruiting NCT05589246 - Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure N/A
Recruiting NCT05572190 - Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects Phase 1
Terminated NCT04716413 - Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Phase 4
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Not yet recruiting NCT06317844 - Examination of Psychological and Physiological Pathways Linking Gratitude and Pain N/A
Withdrawn NCT02957097 - Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures Phase 4
Terminated NCT02599870 - Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures N/A
Completed NCT02565342 - Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery Phase 4
Completed NCT02380989 - Integrative Ayurveda Healing Relieves Minor Sports Injury Pain Phase 2
Completed NCT02984098 - 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose Phase 4
Completed NCT03107338 - Preventive Treatment of Pain After Dental Implant Surgery Phase 4
Completed NCT02489630 - Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department Phase 4
Completed NCT02817477 - Intranasal Ketamine for Acute Traumatic Pain Phase 4