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
Verified date | October 2018 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center Moses Division Emergency Department | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center | National Institute on Aging (NIA) |
United States,
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 |
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