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Phase 3 N=162 Randomized Quadruple-blind Treatment

IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

Acute Pain

Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment — 6.2; 5.4 units on a scale — p=0.08

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
IV acetaminophen (Drug); IV placebo (Drug); hydromorphone (Drug)
Age
Adult · 21+ yrs
Sex
All
Sponsor
Albert Einstein College of Medicine
Primary completion
May 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment
6.2; 5.4 0.08
SECONDARY
Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication
2; 2 0.989
SECONDARY
Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications
2; 4 0.414
SECONDARY
Percentage of Patients Who Want Additional Analgesics
21; 29 0.153

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).

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03553498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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