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IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

Primary Purpose

Acute Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

IV acetaminophen

IV placebo

hydromorphone

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring pain, opioid analgesics, Emergency Department, randomized controlled trial, acetaminophen, hydromorphone

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV hydromorphone and IV acetaminophen

IV hydromorphone and placebo

Arm Description

1000 mg IV acetaminophen administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes

100 ml IV normal saline administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT03553498

First Posted

May 10, 2018

Last Updated

February 9, 2022

Sponsor

Albert Einstein College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03553498

Brief Title

IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

November 27, 2018 (Actual)

Primary Completion Date

May 15, 2019 (Actual)

Study Completion Date

May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Albert Einstein College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain

Keywords

pain, opioid analgesics, Emergency Department, randomized controlled trial, acetaminophen, hydromorphone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Randomized Clinical Trial

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

162 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV hydromorphone and IV acetaminophen

Arm Type

Experimental

Arm Description

1000 mg IV acetaminophen administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes

Arm Title

IV hydromorphone and placebo

Arm Type

Placebo Comparator

Arm Description

100 ml IV normal saline administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes

Intervention Type

Drug

Intervention Name(s)

IV acetaminophen

Other Intervention Name(s)

Ofirmev

Intervention Description

acetaminophen given intravenously

Intervention Type

Drug

Intervention Name(s)

IV placebo

Other Intervention Name(s)

normal saline

Intervention Description

given intravenously

Intervention Type

Drug

Intervention Name(s)

hydromorphone

Other Intervention Name(s)

Dilaudid

Intervention Description

hydromorphone given intravenously

Primary Outcome Measure Information:

Title

Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment

Description

Time Frame

Before treatment to 60 minutes after treatment

Secondary Outcome Measure Information:

Title

Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication

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

Time Frame

Baseline to 60 minutes post-baseline

Title

Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications

Description

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

Title

Percentage of Patients Who Want Additional Analgesics

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Polly Bijur

Organizational Affiliation

Albert Einstein College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

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