Acute PainPhase 3NCT03553498
IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients
A Phase 3 study testing IV acetaminophen and hydromorphone in people with Acute Pain, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- IV acetaminophen and hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2018to 15 May 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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
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).
Read the 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.
- Conditions
- Acute Pain
- Being tested
- IV acetaminophen, IV placebo, hydromorphone
- Keywords
- pain, opioid analgesics, Emergency Department, randomized controlled trial, acetaminophen, hydromorphone
- Medical subject headings
- Acute Pain, Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV acetaminophenDrug
Also called Ofirmev
acetaminophen given intravenously
IV placeboDrug
Also called normal saline
given intravenously
hydromorphoneDrug
Also called Dilaudid
hydromorphone given intravenously
| Study group | Role | What they receive |
|---|---|---|
| IV hydromorphone and IV acetaminophen | Experimental | 1000 mg IV acetaminophen administered over 5-10 minutes
1 mg hydromorphone administered over 5-10 minutes Receives: Drug: IV acetaminophen; Drug: hydromorphone |
| IV hydromorphone and placebo | Placebo comparator | 100 ml IV normal saline administered over 5-10 minutes
1 mg hydromorphone administered over 5-10 minutes Receives: Drug: IV placebo; Drug: hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before treatment to 60 minutes after treatment
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Immediately after administration of study medication to 120 minutes after administration of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start27 Nov 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polly Bijur, Albert Einstein College of Medicine
- Investigators
- Polly Bijur, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553498
- Sponsor's protocol ID
- 2018-8886
- Status last verified
- Feb 2022
- First submitted
- 10 May 2018
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03553498
- Acronym / sponsor ID
- 2018-8886
- Conditions
- Acute Pain
- Keywords
- pain, opioid analgesics, Emergency Department, randomized controlled trial, acetaminophen, hydromorphone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| IV hydromorphone and IV acetaminophen | Experimental | Drug: IV acetaminophen, Drug: hydromorphone1000 mg IV acetaminophen administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes |
| IV hydromorphone and placebo | Placebo comparator | Drug: IV placebo, Drug: hydromorphone100 ml IV normal saline administered over 5-10 minutes 1 mg hydromorphone administered over 5-10 minutes |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV acetaminophenAlso: Ofirmevacetaminophen given intravenously | Drug | IV hydromorphone and IV acetaminophen |
| IV placeboAlso: normal salinegiven intravenously | Drug | IV hydromorphone and placebo |
| hydromorphoneAlso: Dilaudidhydromorphone given intravenously | Drug | IV hydromorphone and IV acetaminophen, IV hydromorphone and placebo |
Primary outcome
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
3 secondary outcomes
Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication
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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Polly Bijur principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV acetaminophen and hydromorphone in people with Acute Pain, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment (time frame: Before treatment to 60 minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.