Hip FracturePhase 4NCT02774148
Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
A Phase 4 study testing IV Acetaminophen and PO Acetaminophen in people with Hip Fracture, run by Corewell Health West at 1 site in United States.
Trial summary
The primary objective is to determine if intravenous acetaminophen decreases pain scores and the amount of morphine equivalence received as compared to oral acetaminophen in patients greater than 65 years old after sustaining a hip fracture. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- IV Acetaminophen and PO Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2016
- 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, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Age ≥ 65 years.
- Low energy mechanism.
- Hip fracture fixation performed within 48 hours of injury.
- English speaking.
- Anticipated medical optimization for operative fixation.
- No other major trauma.
Who cannot join
- Unable to provide informed consent (dementia, limited decision making capacity)
- Admitted by medical service for significant co-morbidities
- Retained hardware around the affected hip
- Infection around the affected hip
- Transfer patients with a length of stay > 24 hours at the transferring hospital
- Known allergy to acetaminophen
Show all 12Show fewer
- Current use of narcotics
- Receiving a regional anesthetic block at any point during the hospitalization
- Known history of hepatic disease (hepatitis, cirrhosis)
- Weight < 50kg
- Prisoner
- Involved in another clinical trial that would interfere with the intervention of this study
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to determine if intravenous acetaminophen decreases pain scores and the amount of morphine equivalence received as compared to oral acetaminophen in patients greater than 65 years old after sustaining a hip fracture.
Read the detailed description
Surgeons involved in this research agree to the randomization of patients into one of two groups. After informed consent, patients will be randomly assigned in a 1:1 ratio to the treatment group or the control group.
Group 1: This group will serve as the control group, and will be scheduled to receive one gram (1g) acetaminophen PO every 8 hours.
Group 2: This group will serve as the treatment group, and will be scheduled to receive one gram (1g) acetaminophen IV every 8 hours
The standardized pain control protocol for hip fracture patients will be initiated for all patients. The pain protocol will be initiated at hospital admission, and after three postoperative doses of the group assigned acetaminophen all patients will be switched to one gram scheduled acetaminophen PO in preparation for hospital discharge.
- Conditions
- Hip Fracture
- Being tested
- IV Acetaminophen, PO Acetaminophen
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
Also called Ofirmev
The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.
PO AcetaminophenDrug
Also called Tylenol
The patient will receive 1,000mg po Acetaminophen every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| PO Acetaminophen | Active comparator | 1,000mg Acetaminophen po every 8 hours until discharge. Receives: Drug: PO Acetaminophen |
| IV Acetaminophen | Experimental | 1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge. Receives: Drug: IV Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain scores will be compared between the two groups.
Measured: 6 days
Secondary outcomes (4)
The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.
The amount of opioid pain medication a patient receives will be recorded and the Morphine equivalents will be determined by an opioid dose calculator. The morphine equivalents will be compared between the two groups.
Measured: 6 days
Timing of First Day of Ambulation.
The timing of the first day of ambulation will be compared between the two groups.
Measured: 6 days
Distance Ambulated
The distance ambulated will be compared between the two groups.
Measured: 6 days
Hospital Stay
Length of hospital stay will be compared between the two groups.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Proved difficult to consent patient population due to comorbidities
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 Hip FractureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew R. Fras, MD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774148
- Sponsor's protocol ID
- 2016-225
- Status last verified
- Sep 2023
- First submitted
- 9 May 2016
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
- ClinicalTrials.gov ID
- NCT02774148
- Acronym / sponsor ID
- 2016-225
- Conditions
- Hip Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Proved difficult to consent patient population due to comorbidities
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Posted 7 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine if intravenous acetaminophen decreases pain scores and the amount of morphine equivalence received as compared to oral acetaminophen in patients greater than 65 years old after sustaining a hip fracture.
Detailed description
Surgeons involved in this research agree to the randomization of patients into one of two groups. After informed consent, patients will be randomly assigned in a 1:1 ratio to the treatment group or the control group.
Group 1: This group will serve as the control group, and will be scheduled to receive one gram (1g) acetaminophen PO every 8 hours.
Group 2: This group will serve as the treatment group, and will be scheduled to receive one gram (1g) acetaminophen IV every 8 hours
The standardized pain control protocol for hip fracture patients will be initiated for all patients. The pain protocol will be initiated at hospital admission, and after three postoperative doses of the group assigned acetaminophen all patients will be switched to one gram scheduled acetaminophen PO in preparation for hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PO Acetaminophen | Active comparator | Drug: PO Acetaminophen1,000mg Acetaminophen po every 8 hours until discharge. |
| IV Acetaminophen | Experimental | Drug: IV Acetaminophen1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Age ≥ 65 years.
- Low energy mechanism.
- Hip fracture fixation performed within 48 hours of injury.
- English speaking.
Key exclusion criteria (12 listed)
- Unable to provide informed consent (dementia, limited decision making capacity)
- Admitted by medical service for significant co-morbidities
- Retained hardware around the affected hip
- Infection around the affected hip
- Transfer patients with a length of stay > 24 hours at the transferring hospital
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: OfirmevThe patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively. | Drug | IV Acetaminophen |
| PO AcetaminophenAlso: TylenolThe patient will receive 1,000mg po Acetaminophen every 8 hours. | Drug | PO Acetaminophen |
Primary outcome
Pain Score
Time frame: 6 days
Pain scores will be compared between the two groups.
4 secondary outcomes
The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.
Time frame: 6 days
Timing of First Day of Ambulation.
Time frame: 6 days
Distance Ambulated
Time frame: 6 days
Hospital Stay
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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.
Andrew R. Fras, MD principal investigator
Corewell Health West
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 and PO Acetaminophen in people with Hip Fracture, run by Corewell Health West 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 28 Sep 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 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 7 Feb 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?
Pain Score (time frame: 6 days). 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 28 Sep 2023.