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

Study Overview
=================
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.

Official Title
-----------------
An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: Acetaminophen 1000mg IV
* Drug: Hydromorphone 0.5 mg IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal to 65 or greater Pain onset within 7 days with severe pain Has capacity to provide informed consent Understanding English or Spanish 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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetaminophen 1000mg IV<br>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. | Drug: Acetaminophen 1000mg IV<br>* 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push<br>|
| Active Comparator: Hydromorphone 0.5mg IV<br>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. | Drug: Hydromorphone 0.5 mg IV<br>* 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |