Acute Pain Clinical Trial
Official title:
An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain
Verified date | February 2023 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.
Status | Completed |
Enrollment | 162 |
Est. completion date | March 23, 2022 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. Age equal to 65 or greater 2. Pain onset within 7 days with severe pain 3. Has capacity to provide informed consent 4. Understanding English or Spanish Exclusion Criteria: 1. Use of tramadol or opioids within 7 days 2. Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours 3. Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies 4. Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration 5. Alcohol intoxication 6. Systolic blood pressure: < 100 mmHg 7. Heart rate: < 60 beats per minute 8. Oxygen saturation: < 95% on room air 9. Use of monoamine oxidase (MAO) inhibitors in the past 30 days 10. Use of transdermal pain patch or oral opioid > 10 days in the prior month 11. Prior enrollment in the same study |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Improvement in NRS Pain Score | Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of >=1.3 points on the 0-10 scale. | 60 minutes following administration of medication | |
Secondary | Need for Rescue Medication | Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course. | 120 minutes following administration of medication | |
Secondary | Improvement in NPS Pain Score by >=50% | The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes. | 60 minutes after administration of medication |
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 |