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IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT03553498
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Polly Bijur, Albert Einstein College of Medicine

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).

Condition or disease Intervention/treatment Phase
Acute Pain Drug: IV acetaminophen Drug: IV placebo Drug: hydromorphone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The pharmacist working in an area inaccessible to ED staff will ensure blinding by creating identical vials containing either 1000 mg acetaminophen in 100 ml normal saline or 100 ml normal saline placebo and numbering them sequentially for use in this study.
Primary Purpose: Treatment
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
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV Acetaminophen
1000 mg IV acetaminophen administered over 5-10 minutes
Drug: IV acetaminophen
acetaminophen given intravenously
Other Name: Ofirmev

Drug: hydromorphone
hydromorphone given intravenously
Other Name: Dilaudid

Placebo Comparator: IV hydromorphone and placebo
100 ml IV normal saline administered over 5-10 minutes
Drug: IV placebo
given intravenously
Other Name: normal saline

Drug: hydromorphone
hydromorphone given intravenously
Other Name: Dilaudid




Primary Outcome Measures :
  1. Change in Numerical Rating Scale of pain (NRS) baseline to 60 minutes post-baseline [ Time Frame: Baseline (end of administration of medication) to 60 minutes post-baseline ]
    The between group difference in change in NRS pain scores from baseline 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.


Secondary Outcome Measures :
  1. Proportion of patients who choose to forego additional pain medication at 60 minutes post-baseline [ Time Frame: Baseline to 60 minutes post-baseline ]
    Difference in proportion of patients who choose to forego additional pain medicine when asked the following question: "Do you want more pain medication?" 60 minutes after baseline

  2. Receipt of additional pain medication before 60 minutes post-baseline ("rescue" medication) [ Time Frame: Baseline to 60 minutes post-baseline ]
    Difference in proportion of patients who receive additional pain medication before 60 minutes post-baseline ("rescue" medication)

  3. Receipt of additional pain medication between 60 and 120 minutes post-baseline [ Time Frame: 60 and 120 minutes post-baseline ]
    Difference in proportion of patients who receive additional pain medication between 60 and 120 minutes post-baseline.

  4. Incidence of side effects [ Time Frame: Between baseline and 120 minutes post-baseline ]
    Difference in proportion of patients who experience one or more episodes of nausea, vomiting, or pruritus

  5. Incidence of adverse events [ Time Frame: Between baseline and 120 minutes post-baseline ]
    Difference in proportion of patients who experience one or more episodes of oxygen desaturation below 95%, hypoventilation -respiratory rate (RR) per minute below 10, hypotension - systolic blood pressure (SBP) below 90 mmHg, or bradycardia - heart rate (HR) below 50 beats per minute



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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • SBP <100 mmHg
  • HR < 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553498


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Polly Bijur Albert Einstein College of Medicine

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Responsible Party: Polly Bijur, Professor of Emergency Medicine, Epidemiology and Population Health, and of Pediatrics, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03553498     History of Changes
Other Study ID Numbers: 2018-8886
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Polly Bijur, Albert Einstein College of Medicine:
pain
opioid analgesics
Emergency Department
randomized controlled trial
acetaminophen
hydromorphone
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Hydromorphone
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants