Acute PainPhase 4NCT02621619

IV Acetaminophen as an Analgesic Adjunct

A Phase 4 study testing IV acetaminophen + 0.5 mg IV hydromorphone and Normal saline + 0.5 mg IV hydromorphone 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

To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Acute Pain
What is being tested?: IV acetaminophen + 0.5 mg IV hydromorphone and Normal saline + 0.5 mg IV hydromorphone
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 159 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Oct 2017
Phase: Phase 4
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

Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician

Who cannot join

Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
Prior adverse reaction to hydromorphone, morphine, or acetaminophen.
Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
Heart Rate (HR) < 60/min: Opioids can cause bradycardia.

Show all 9Show fewer

Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
Patients using transdermal pain patches

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center Moses Division Emergency Department
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients

To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients.

Read the detailed description

A randomized controlled trial to determine the efficacy of 1 gram IV acetaminophen as an analgesic adjunct to 0.5 mg IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.

Conditions: Acute Pain
Being tested: IV acetaminophen + 0.5 mg IV hydromorphone, Normal saline + 0.5 mg IV hydromorphone
Keywords: Older adults, Elderly, Acute pain, IV acetaminophen, IV hydromorphone, Analgesia, Adjunctive analgesia
Medical subject headings: Acute Pain, Agnosia

What participants receive

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

IV acetaminophen + 0.5 mg IV hydromorphoneDrug
Also called Ofirmev
1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphoneDrug
Also called Placebo
100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

Study groups in NCT02621619
Study group	Role	What they receive
IV acetaminophen + 0.5 mg IV hydromorphone	Experimental	1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone Receives: Drug: IV acetaminophen + 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone	Placebo comparator	100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone Receives: Drug: Normal saline + 0.5 mg IV hydromorphone

What is being measured

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

Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).
Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)].
Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given.
Measured: baseline and 60 minutes after medication was infused

Secondary outcomes (1)

Change in Pain Intensity Over Time
Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).
Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)].
Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes
Measured: baseline to 5 min, 15 min, 30 min, and 45 minutes

Timeline

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

Mar 2016Oct 2017

First posted3 Dec 2015 (estimated)
Study startMar 2016
Primary completionOct 2017
Study completionOct 2017

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.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02621619
Sponsor's protocol ID: 2015-5369
Other IDs: 7K23AG033100-07
Status last verified: Oct 2018
First submitted: 21 Nov 2015
Last updated: 8 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes

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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All Acute Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients
ClinicalTrials.gov ID: NCT02621619
Acronym / sponsor ID: 2015-5369
Conditions: Acute Pain
Keywords: Older adults, Elderly, Acute pain, IV acetaminophen, IV hydromorphone, Analgesia, Adjunctive analgesia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Mar 2016 (actual)
Primary completion: Oct 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 3 Dec 2015 (estimated)
Results: Posted 8 Nov 2018

Clinical summary

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

To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients.

Detailed description

A randomized controlled trial to determine the efficacy of 1 gram IV acetaminophen as an analgesic adjunct to 0.5 mg IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.

Study design

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

Arm	Type	Receives
IV acetaminophen + 0.5 mg IV hydromorphone	Experimental	Drug: IV acetaminophen + 0.5 mg IV hydromorphone1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone	Placebo comparator	Drug: Normal saline + 0.5 mg IV hydromorphone100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone

Who may qualify

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

Key inclusion criteria (1 listed)

Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician

Key exclusion criteria (9 listed)

Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
Prior adverse reaction to hydromorphone, morphine, or acetaminophen.
Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.

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 acetaminophen + 0.5 mg IV hydromorphoneAlso: Ofirmev1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone	Drug	IV acetaminophen + 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphoneAlso: Placebo100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone	Drug	Normal saline + 0.5 mg IV hydromorphone

Primary outcome

Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
Time frame: baseline and 60 minutes after medication was infused
Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given.

1 secondary outcome

Change in Pain Intensity Over Time
Time frame: baseline to 5 min, 15 min, 30 min, and 45 minutes

Results and safety

Results posted to the registry on 8 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV Acetaminophen + 0.5 mg IV Hydromorphone	80	80
Placebo + 0.5 mg IV Hydromorphone	79	79

Primary outcome: Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused

Time frame: baseline and 60 minutes after medication was infused. Mean (Standard Deviation). Unit: units on a scale

Measure	IV Acetaminophen + 0.5 mg IV Hydromorphone n = 80	Placebo + 0.5 mg IV Hydromorphone n = 79
Value	5.8 (3.2)	5.2 (3.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 60 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Acetaminophen + 0.5 mg IV Hydromorphone	0 of 80 (0%)	16 of 80 (20%)	0 of 80
Placebo + 0.5 mg IV Hydromorphone	0 of 79 (0%)	13 of 79 (16.5%)	0 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Pain

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Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
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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.

Andrew Chang, MD, MS principal investigator

Albany Medical College

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing IV acetaminophen + 0.5 mg IV hydromorphone and Normal saline + 0.5 mg IV hydromorphone 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 1 inclusion and 9 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 8 Nov 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 8 Nov 2018). 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 Pain Intensity, Baseline to 60 Minutes After Medication Infused (time frame: baseline and 60 minutes after medication was infused). 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 NCT02621619.

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 8 Nov 2018; AzTrials last refreshed its copy on 1 Nov 2026.