Acute Pain Clinical Trial
Official title:
Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone
Verified date | April 2018 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.
Status | Completed |
Enrollment | 350 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's Emergency Department (ED). 2. Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature. 3. ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids Exclusion Criteria: 1. Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics. 2. Prior adverse reaction to opioids. 3. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. 4. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception. 5. Systolic Blood Pressure <90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension. 6. Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled. 7. Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. 8. CO2 measurement greater than 46: In accordance with standard protocol, three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46 then the patient will be excluded from the study. The 3 subsets are as follows: - All patients who have a history of chronic obstructive pulmonary disease (COPD) - All patients who report a history of asthma together with greater than a 20 pack-year smoking history - All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center Moses Division Emergency Department | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients With Satisfactory Pain Management at 60 Minutes | The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes. | 60 minutes | |
Secondary | Mean Change in Pain Intensity From Baseline to 60 Minutes | Pain intensity is measured in numerical rating scale (NRS) units from 0 ("no pain") to 10 ("worst pain imaginable"). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department. | 60 minutes | |
Secondary | Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes | 60 minutes |
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 | |
Completed |
NCT02565342 -
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
|
Phase 4 | |
Terminated |
NCT02599870 -
Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
|
N/A | |
Completed |
NCT02984098 -
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
|
Phase 4 | |
Completed |
NCT02380989 -
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
|
Phase 2 | |
Completed |
NCT02489630 -
Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
|
Phase 4 | |
Completed |
NCT03107338 -
Preventive Treatment of Pain After Dental Implant Surgery
|
Phase 4 | |
Completed |
NCT02817477 -
Intranasal Ketamine for Acute Traumatic Pain
|
Phase 4 |