Brief Summary
The goal of this randomized clinical trial is to compare the analgesic efficacy and side effect profile of IV acetaminophen as an analgesic adjunctive medication to IV hydromorphone for the treatment of acute pain experienced by patients in the Emergency Department (ED).
Brief Title
IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients
Detailed Description
Multimodal treatment of pain is a commonly used strategy to control pain by combining analgesics with different and complementary mechanisms of action. Oral acetaminophen combined with opioids is a mainstay of treatment of mild to moderate pain, while the use of IV opioids is the standard for treatment of severe pain in the Emergency Department. An IV formulation of acetaminophen is widely used in Europe and has recently been approved in the US. It has been studied for treatment of acute post-operative pain and renal colic.
This randomized trial was designed to assess the effectiveness of the combination of IV acetaminophen and IV hydromorphone as a strategy to provide more effective treatment of acute severe pain in the Emergency Department with the possibility of reducing opioid consumption. All patients received 1 mg of IV hydromorphone. They were then randomized to receive either 1 g of IV acetaminophen or 100 mL of normal saline placebo. Measures of pain, vital signs, and presence of side effects were obtained immediately before IV hydromorphone was administered. Following receipt of the acetaminophen or placebo these same variables were measured at 15 minute intervals for the next 120 minutes. Additional analgesics were administered if patients requested them. Subsequent care of the patients was at the discretion of the treating attending physician.
This randomized trial was designed to assess the effectiveness of the combination of IV acetaminophen and IV hydromorphone as a strategy to provide more effective treatment of acute severe pain in the Emergency Department with the possibility of reducing opioid consumption. All patients received 1 mg of IV hydromorphone. They were then randomized to receive either 1 g of IV acetaminophen or 100 mL of normal saline placebo. Measures of pain, vital signs, and presence of side effects were obtained immediately before IV hydromorphone was administered. Following receipt of the acetaminophen or placebo these same variables were measured at 15 minute intervals for the next 120 minutes. Additional analgesics were administered if patients requested them. Subsequent care of the patients was at the discretion of the treating attending physician.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Pain
Eligibility Criteria
Inclusion Criteria:
* Pain with onset within 7 days of the ED visit
* 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.
* ED attending physician's judgement that patient is not a chronic user of opioids or acetaminophen
* 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; 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 or nurse
* Not at risk of suicide assessed by triage nurse
* Systolic blood pressure \<100 mmHg
* Heart Rate \< 60/min
* Oxygen saturation \< 95% on room air:
* Use of monoamine oxidase (MAO) inhibitors in past 30 days
* Use of transdermal pain patches
* Taking any medication that might interact with one of the study medications, such as a selective serotonin reuptake inhibitor (SSRI) or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritonavir, terbinafine or St. John's Wort.
* Patients who have been previously enrolled in this same study
* Pain with onset within 7 days of the ED visit
* 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.
* ED attending physician's judgement that patient is not a chronic user of opioids or acetaminophen
* 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; 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 or nurse
* Not at risk of suicide assessed by triage nurse
* Systolic blood pressure \<100 mmHg
* Heart Rate \< 60/min
* Oxygen saturation \< 95% on room air:
* Use of monoamine oxidase (MAO) inhibitors in past 30 days
* Use of transdermal pain patches
* Taking any medication that might interact with one of the study medications, such as a selective serotonin reuptake inhibitor (SSRI) or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritonavir, terbinafine or St. John's Wort.
* Patients who have been previously enrolled in this same study
Inclusion Criteria
Inclusion Criteria:
* Pain with onset within 7 days of the ED visit
* 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.
* ED attending physician's judgement that patient is not a chronic user of opioids or acetaminophen
* Patients must be able to understand English or Spanish.
* Pain with onset within 7 days of the ED visit
* 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.
* ED attending physician's judgement that patient is not a chronic user of opioids or acetaminophen
* Patients must be able to understand English or Spanish.
Gender
All
Gender Based
false
Keywords
pain
opioid analgesics
Emergency Department
randomized controlled trial
acetaminophen
hydromorphone
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
NCT03553498
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2018-8886
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Randomized Clinical Trial of IV Acetaminophen as an Adjuvant Analgesic to IV Hydromorphone for Treatment of Acute Severe Pain in Non-Elderly Emergency Department Patients
Primary Outcomes
Outcome Description
The between group difference in change in NRS pain scores from before administration of study medications to 60 minutes post administration of study medications. The NRS is a previously validated and reproducible measure of pain intensity ranging from 0 = no pain, to 10 = worst possible pain. Higher values indicate more pain relief from before treatment to 60 minutes after treatment
Outcome Measure
Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment
Outcome Time Frame
Before treatment to 60 minutes after treatment
Secondary Outcomes
Outcome Description
Difference in percentage of patients who received additional pain medication within 60 minutes of administration of study medication in the two arms of the study
Outcome Time Frame
Baseline to 60 minutes post-baseline
Outcome Measure
Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication
Outcome Description
Difference in percentage of patients who received additional pain medication between 61 and 120 minutes after administration of study medication by study group
Outcome Time Frame
61 to 120 minutes post-baseline
Outcome Measure
Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications
Outcome Description
Number of patients who answer "yes" to question: "Do you want more pain medication" divided by number of patients
Outcome Time Frame
Immediately after administration of study medication to 120 minutes after administration of study medication
Outcome Measure
Percentage of Patients Who Want Additional Analgesics
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
Polly Bijur
Investigator Email
polly.bijur@einsteinmed.org
Investigator Phone
718-430-4217