IV Acetaminophen as an Analgesic Adjunct

Acute Pain Clinical Trial

Official title:

Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621619
• Other study ID #: 2015-5369
• Secondary ID: 7K23AG033100-07
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients.

Description:

A randomized controlled trial to determine the efficacy of 1 gram IV acetaminophen as an analgesic adjunct to 0.5 mg IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician

Exclusion Criteria:

• Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.

• Prior adverse reaction to hydromorphone, morphine, or acetaminophen.

• Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.

• Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.

• Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.

• Heart Rate (HR) < 60/min: Opioids can cause bradycardia.

• Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.

• Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.

• Patients using transdermal pain patches

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• IV acetaminophen + 0.5 mg IV hydromorphone
1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
• Normal saline + 0.5 mg IV hydromorphone
100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

Locations

Country	Name	City	State
United States	Montefiore Medical Center Moses Division Emergency Department	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused	Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).; Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)].; Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given.	baseline and 60 minutes after medication was infused
Secondary	Change in Pain Intensity Over Time	Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).; Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)].; Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes	baseline to 5 min, 15 min, 30 min, and 45 minutes