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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Use of tramadol or opioids within 7 days
Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
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
Alcohol intoxication
Systolic blood pressure: < 100 mmHg
Heart rate: < 60 beats per minute
Oxygen saturation: < 95% on room air
Use of monoamine oxidase (MAO) inhibitors in the past 30 days
Use of transdermal pain patch or oral opioid > 10 days in the prior month
Prior enrollment in the same study

Arm && Interventions

Group	Intervention	Description
Acetaminophen 1000mg IV	Acetaminophen 1000mg IV	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.
Hydromorphone 0.5mg IV	Hydromorphone 0.5 mg IV	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.

Primary Outcome Measures

Name	Time	Method
Clinical Improvement in NRS Pain Score	60 minutes following administration of medication	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.

Secondary Outcome Measures

Name	Time	Method
Need for Rescue Medication	120 minutes following administration of medication	Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course.
Improvement in NPS Pain Score by >=50%	60 minutes after administration of medication	The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes.