Brief Summary
The purpose of the current study is to compare the analgesic efficacy of intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the ED.
Brief Title
Acetaminophen IV vs Hydromorphone IV in the ED
Detailed Description
This is a randomized, double-blind placebo-controlled clinical trial comparing intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the Emergency Department. Enrolled subjects presenting to the ED with acute pain will be randomized to receive either acetaminophen 1g IV or hydromorphone 1mg IV.
Completion Date
Completion Date Type
Actual
Conditions
Pain, Acute
Eligibility Criteria
Inclusion Criteria:
* Age 21 through 64 years of age: This is a study of adult ED patients.
* Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in the ED literature.
* ED attending physician's judgment that the patient's pain warrants IV opioids.
* ED attending physician's judgment that the patient has capacity to provide informed consent.
* Patients must be able to understand English or Spanish.
Exclusion Criteria:
* Use of opioids or tramadol within past 24 hours.
* Use of acetaminophen or non-steroidal anti-inflammatory medication within the previous 8 hours.
* Prior adverse reaction to opioids 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.
* Medical condition that might affect metabolism or opioid analgesics or acetaminophen such as hepatitis, renal insufficiency or failure, hypo- or hyper-thyroidism, Addison's or Cushing's disease
* Pregnant or breastfeeding
* Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
* SBP \<100 mmHg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
* 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 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: pain patches may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments.
* Taking any medication that might interact with one of the study medications, such as SSRI or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine or St. John's Wort.
* Patients who have been previously enrolled in this same study: Patients may only be enrolled once.
* Age 21 through 64 years of age: This is a study of adult ED patients.
* Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in the ED literature.
* ED attending physician's judgment that the patient's pain warrants IV opioids.
* ED attending physician's judgment that the patient has capacity to provide informed consent.
* Patients must be able to understand English or Spanish.
Exclusion Criteria:
* Use of opioids or tramadol within past 24 hours.
* Use of acetaminophen or non-steroidal anti-inflammatory medication within the previous 8 hours.
* Prior adverse reaction to opioids 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.
* Medical condition that might affect metabolism or opioid analgesics or acetaminophen such as hepatitis, renal insufficiency or failure, hypo- or hyper-thyroidism, Addison's or Cushing's disease
* Pregnant or breastfeeding
* Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
* SBP \<100 mmHg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
* 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 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: pain patches may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments.
* Taking any medication that might interact with one of the study medications, such as SSRI or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine or St. John's Wort.
* Patients who have been previously enrolled in this same study: Patients may only be enrolled once.
Inclusion Criteria
Inclusion Criteria:
* Age 21 through 64 years of age: This is a study of adult ED patients.
* Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in the ED literature.
* ED attending physician's judgment that the patient's pain warrants IV opioids.
* ED attending physician's judgment that the patient has capacity to provide informed consent.
* Patients must be able to understand English or Spanish.
* Age 21 through 64 years of age: This is a study of adult ED patients.
* Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in the ED literature.
* ED attending physician's judgment that the patient's pain warrants IV opioids.
* ED attending physician's judgment that the patient has capacity to provide informed consent.
* Patients must be able to understand English or Spanish.
Gender
All
Gender Based
false
Keywords
Acetaminophen
Hydromorphone
Emergency Department
Narcotics
Analgesics, Opioid
Analgesics, Non-Narcotic
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
64 Years
Minimum Age
21 Years
NCT Id
NCT03107481
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-7296
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Acetaminophen 1g IV vs Hydromorphone 1mg IV for the Treatment of Acute Pain in the Emergency Department
Primary Outcomes
Outcome Description
Between group difference in change in NRS pain scores from baseline
Outcome Measure
NRS Change at 60 minutes
Outcome Time Frame
60 minutes
Secondary Outcomes
Outcome Description
Difference in proportion of patients who choose to forego additional pain medication
Outcome Time Frame
60 minutes
Outcome Measure
Forego Additional Pain Medication
Outcome Description
Difference in proportion of patients who receive additional pain medication before primary outcome
Outcome Time Frame
Before 60 minutes
Outcome Measure
Receive Rescue Medication
Outcome Description
Difference in proportion of patients who experience medication side effects grouped by GI (vomiting, nausea), dermatologic (pruritis, rash), and CNS (dizziness, drowsiness) categories.
Outcome Time Frame
120 Minutes
Outcome Measure
Experience Medication Side Effects
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
64
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Douglas Barnaby
Investigator Email
dbarnaby@montefiore.org
Investigator Phone
718-920-6626