Acute PainPhase 2NCT03521102

Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED

A Phase 2 study testing Acetaminophen 1000mg IV and Hydromorphone 0.5 mg IV in people with Acute Pain, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Acute Pain
What is being tested?: Acetaminophen 1000mg IV and Hydromorphone 0.5 mg IV
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 1 siteUnited States
Study dates: 20 Aug 2018to 23 Mar 2022
Phase: Phase 2
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Age equal to 65 or greater
Pain onset within 7 days with severe pain
Has capacity to provide informed consent
Understanding English or Spanish

Who cannot join

Use of tramadol or opioids within 7 days
Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration
Alcohol intoxication
Systolic blood pressure: < 100 mmHg

Show all 11Show fewer

Heart rate: < 60 beats per minute
Oxygen saturation: < 95% on room air
Use of monoamine oxidase (MAO) inhibitors in the past 30 days
Use of transdermal pain patch or oral opioid > 10 days in the prior month
Prior enrollment in the same study

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain

Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.

Conditions: Acute Pain
Being tested: Acetaminophen 1000mg IV, Hydromorphone 0.5 mg IV
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acetaminophen 1000mg IVDrug
1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push
Hydromorphone 0.5 mg IVDrug
100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push

Study groups in NCT03521102
Study group	Role	What they receive
Acetaminophen 1000mg IV	Experimental	NRS pain score will be obtained at baseline, 15, 30, 45, 60, 90, 120, and 180 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes. Receives: Drug: Acetaminophen 1000mg IV
Hydromorphone 0.5mg IV	Active comparator	NRS pain score will be checked at 5 minutes and every 15 minutes thereafter for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes. Receives: Drug: Hydromorphone 0.5 mg IV

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Improvement in NRS Pain Score
Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of >=1.3 points on the 0-10 scale.
Measured: 60 minutes following administration of medication

Secondary outcomes (2)

Need for Rescue Medication
Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course.
Measured: 120 minutes following administration of medication
Improvement in NPS Pain Score by >=50%
The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes.
Measured: 60 minutes after administration of medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 201823 Mar 2022

First posted11 May 2018
Study start20 Aug 2018
Primary completion30 Oct 2021
Study completion23 Mar 2022

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute PainStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03521102
Sponsor's protocol ID: 2018-8876
Status last verified: Feb 2023
First submitted: 26 Apr 2018
Last updated: 2 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Kolli S, Friedman BW, Latev A, Chang AK, Naeem F, Feliciano C, Afrifa F, Walker C, Izzo A, Irizarry E. A Randomized Study of Intravenous Hydromorphone Versus Intravenous Acetaminophen for Older Adult Patients with Acute Severe Pain. Ann Emerg Med. 2022 Nov;80(5):432-439. doi: 10.1016/j.annemergmed.2022.06.016. Epub 2022 Aug 12.
PubMed 35965162

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain
ClinicalTrials.gov ID: NCT03521102
Acronym / sponsor ID: 2018-8876
Conditions: Acute Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: 20 Aug 2018 (actual)
Primary completion: 30 Oct 2021 (actual)
Study completion: 23 Mar 2022 (actual)
First posted: 11 May 2018 (actual)
Results: Posted 2 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Acetaminophen 1000mg IV	Experimental	Drug: Acetaminophen 1000mg IVNRS pain score will be obtained at baseline, 15, 30, 45, 60, 90, 120, and 180 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes.
Hydromorphone 0.5mg IV	Active comparator	Drug: Hydromorphone 0.5 mg IVNRS pain score will be checked at 5 minutes and every 15 minutes thereafter for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Age equal to 65 or greater
Pain onset within 7 days with severe pain
Has capacity to provide informed consent
Understanding English or Spanish

Key exclusion criteria (11 listed)

Use of tramadol or opioids within 7 days
Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration
Alcohol intoxication

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
Acetaminophen 1000mg IV1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push	Drug	Acetaminophen 1000mg IV
Hydromorphone 0.5 mg IV100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push	Drug	Hydromorphone 0.5mg IV

Primary outcome

Clinical Improvement in NRS Pain Score
Time frame: 60 minutes following administration of medication
Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of >=1.3 points on the 0-10 scale.

2 secondary outcomes

Need for Rescue Medication
Time frame: 120 minutes following administration of medication
Improvement in NPS Pain Score by >=50%
Time frame: 60 minutes after administration of medication

Results and safety

Results posted to the registry on 2 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acetaminophen 1000mg IV	81	81
Hydromorphone 0.5mg IV	81	81

Primary outcome: Clinical Improvement in NRS Pain Score

Time frame: 60 minutes following administration of medication. Count of participants. Unit: Participants

Measure	Acetaminophen 1000mg IV n = 81	Hydromorphone 0.5mg IV n = 81
Value	62	63

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acetaminophen 1000mg IV	0 of 81 (0%)	6 of 81 (7.4%)	0 of 81
Hydromorphone 0.5mg IV	0 of 81 (0%)	10 of 81 (12.3%)	0 of 81

Limitations and caveats (from the sponsor): Enrollment limited to 2 urban EDs, excluding a large number of patients who had been screened. Results may not be generalizable to all older patients with acute severe pain Dose ranging studies were not conducted to help optimize hydromorphone dosage An arbitrary value (1.3) was selected as the minimum clinically important improvement threshold The study relied on the clinical attending physician's judgment of whether opioids were indicated. Would not account for local practices

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35965162Kolli S, Friedman BW, Latev A, Chang AK, Naeem F, Feliciano C, Afrifa F, Walker C, Izzo A, Irizarry E. A Randomized Study of Intravenous Hydromorphone Versus Intravenous Acetaminophen for Older Adult Patients with Acute Severe Pain. Ann Emerg Med. 2022 Nov;80(5):432-439. doi: 10.1016/j.annemergmed.2022.06.016. Epub 2022 Aug 12.
Individual participant dataSharing planned: Undecided

Related trials for Acute Pain

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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.

Benjamin Friedman, MD principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acetaminophen 1000mg IV and Hydromorphone 0.5 mg IV in people with Acute Pain, run by Montefiore Medical Center 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 4 inclusion and 11 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 2023. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 2023). 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?

Clinical Improvement in NRS Pain Score (time frame: 60 minutes following administration of medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03521102, which also lists 1 linked publication.

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 2023.