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

Montefiore Medicine Academic Health System logo

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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