Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Acute Pain

Treatments: Drug: Hydromorphone 0.5 mg IV; Drug: Acetaminophen 1000mg IV

Study type: Interventional

Funder types: Other

Identifiers

NCT03521102

2018-8876

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 2 patient groups

Acetaminophen 1000mg IV

Experimental group

Description:

NRS pain score will be obtained at baseline, 15, 30, 45, 60, 90, 120, and 180 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes.

Treatment:

Drug: Acetaminophen 1000mg IV

Hydromorphone 0.5mg IV

Active Comparator group

Description:

NRS pain score will be checked at 5 minutes and every 15 minutes thereafter for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes.

Treatment:

Drug: Hydromorphone 0.5 mg IV