A Phase 3 interventional study of IV acetaminophen and IV placebo in Acute Pain, sponsored by Albert Einstein College of Medicine. Completed at 1 site in United States. Open to participants aged 21 Years to 64 Years. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Albert Einstein College of Medicine · Phase 3, Interventional, and Treatment
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).
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.
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This study's enrollment of 162 is above the median of 145 across 931 interventional studies indexed under Emergencies.
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Exclusion Criteria:
1000 mg IV acetaminophen administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes
Drug: IV acetaminophen · Drug: hydromorphone
100 ml IV normal saline administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes
Drug: IV placebo · Drug: hydromorphone
acetaminophen given intravenously
Also known as: Ofirmev
given intravenously
Also known as: normal saline
hydromorphone given intravenously
Also known as: Dilaudid
Change in Numerical Rating Scale of Pain (NRS) 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
Time frame: Before treatment to 60 minutes after treatment
Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication
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
Time frame: Baseline to 60 minutes post-baseline
Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications
Difference in percentage of patients who received additional pain medication between 61 and 120 minutes after administration of study medication by study group
Time frame: 61 to 120 minutes post-baseline
Percentage of Patients Who Want Additional Analgesics
Number of patients who answer "yes" to question: "Do you want more pain medication" divided by number of patients
Time frame: Immediately after administration of study medication to 120 minutes after administration of study medication
| Milestone | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo |
|---|---|---|
| Started | 81 | 81 |
| Completed | 80 | 79 |
| Not completed | 1 | 2 |
| Withdrew: Missing primary outcome | 1 | 2 |
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
| units on a scale | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo |
|---|---|---|
| Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment | 6.2 (5.6 to 6.8) | 5.4 (4.7 to 6.1) |
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
| Participants | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo |
|---|---|---|
| Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication | 2 | 2 |
Difference in percentage of patients who received additional pain medication between 61 and 120 minutes after administration of study medication by study group
| Participants | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo |
|---|---|---|
| Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications | 2 | 4 |
Number of patients who answer "yes" to question: "Do you want more pain medication" divided by number of patients
| Participants | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo |
|---|---|---|
| Percentage of Patients Who Want Additional Analgesics | 21 | 29 |
Collected over During the entire study - within 2 hours after administration of study medication. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Hydromorphone and IV Acetaminophen | 0/80 (0%) | 0/80 (0%) | 21/80 (26.3%) |
| IV Hydromorphone and Placebo | 0/79 (0%) | 0/79 (0%) | 22/79 (27.8%) |
| Event | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo |
|---|---|---|
| PruritisGeneral disorders | 11/80 | 12/79 |
| Nausea and/or VomitingGeneral disorders | 6/80 | 8/79 |
| Oxygen DesaturationGeneral disorders | 3/80 | 1/79 |
| HypotensionGeneral disorders | 1/80 | 1/79 |
| BradycardiaGeneral disorders | 0/80 | 1/79 |
| Age, Continuous(years) | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo | Total |
|---|---|---|---|
| Mean | 43.3 ± 12.0 | 43.1 ± 13.5 | 43.2 ± 12.8 |
| Sex: Female, Male(Participants) | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo | Total |
|---|---|---|---|
| Female | 52 | 48 | 100 |
| Male | 28 | 31 | 59 |
| Race/Ethnicity, Customized(Participants) | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo | Total |
|---|---|---|---|
| Race/ethnicity — Hispanic/Latino | 54 | 53 | 107 |
| Race/ethnicity — African-American | 22 | 17 | 39 |
| Race/ethnicity — White | 2 | 5 | 7 |
| Race/ethnicity — Other | 2 | 4 | 6 |
| Region of Enrollment(participants) | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo | Total |
|---|---|---|---|
| United States | 80 | 79 | 159 |
| Location of Pain(Participants) | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo | Total |
|---|---|---|---|
| Abdomen/flank | 70 | 67 | 137 |
| Other | 10 | 12 | 22 |
| Pain Intensity on Numerical Rating Scale(Participants) | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo | Total |
|---|---|---|---|
| 6-7 | 7 | 8 | 15 |
| 8 | 12 | 19 | 31 |
| 9 | 11 | 9 | 20 |
| 10 | 50 | 43 | 93 |
| Nauseated or vomited in Emergency Department before treatment(Participants) | IV Hydromorphone and IV Acetaminophen | IV Hydromorphone and Placebo | Total |
|---|---|---|---|
| Yes - nauseated or vomited | 57 | 52 | 109 |
| No - not nauseated, did not vomit | 23 | 27 | 50 |
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Albert Einstein College of Medicine