- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03553498
IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10467
- Montefiore Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IV hydromorphone and IV acetaminophen
1000 mg IV acetaminophen administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes |
acetaminophen given intravenously
Other Names:
hydromorphone given intravenously
Other Names:
|
Placebo Comparator: IV hydromorphone and placebo
100 ml IV normal saline administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes |
hydromorphone given intravenously
Other Names:
given intravenously
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment
Time Frame: Before treatment to 60 minutes after treatment
|
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
|
Before treatment to 60 minutes after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication
Time Frame: Baseline to 60 minutes post-baseline
|
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
|
Baseline to 60 minutes post-baseline
|
Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications
Time Frame: 61 to 120 minutes post-baseline
|
Difference in percentage of patients who received additional pain medication between 61 and 120 minutes after administration of study medication by study group
|
61 to 120 minutes post-baseline
|
Percentage of Patients Who Want Additional Analgesics
Time Frame: Immediately after administration of study medication to 120 minutes after administration of study medication
|
Number of patients who answer "yes" to question: "Do you want more pain medication" divided by number of patients
|
Immediately after administration of study medication to 120 minutes after administration of study medication
|
Collaborators and Investigators
Investigators
- Principal Investigator: Polly Bijur, Albert Einstein College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Disease Attributes
- Emergencies
- Acute Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Acetaminophen
- Hydromorphone
Other Study ID Numbers
- 2018-8886
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Pain
-
Rajavithi HospitalCompletedTotal Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , CelecoxibThailand
-
Seoul National University HospitalNot yet recruiting
-
Chung-Ang University Gwangmyeong HospitalRecruitingPostoperative Pain, AcuteKorea, Republic of
-
TC Erciyes UniversityCompletedPostoperative Pain, AcuteTurkey
-
Zagazig UniversityRecruiting
-
Mansoura UniversityRecruitingPostoperative Pain, AcuteEgypt
-
University of California, San DiegoActive, not recruitingPostoperative Pain, AcuteUnited States
-
Umraniye Education and Research HospitalNot yet recruiting
-
Sohag UniversityCompletedPostoperative Pain, AcuteEgypt
-
Cairo UniversityNot yet recruitingPostoperative Pain, Acute
Clinical Trials on IV acetaminophen
-
MallinckrodtCompletedFever | Acute PainUnited States
-
MallinckrodtCompletedPostoperative Pain | HysterectomyUnited States
-
Massachusetts General HospitalCompletedPain, Postoperative | Infertility, FemaleUnited States
-
TriHealth Inc.Completed
-
MallinckrodtCompleted
-
Nantes University HospitalRecruiting
-
Milton S. Hershey Medical CenterTerminatedStroke | Subarachnoid HemorrhageUnited States
-
McLaren Regional Medical CenterCadence PharmaceuticalsUnknown
-
MallinckrodtCompleted
-
MallinckrodtCompletedPain | FeverUnited States