Post-op PainPhase 4KHEANCT02244619
PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement
A Phase 4 study testing Oral acetaminophen and IV acetaminophen in people with Post-op Pain, run by Kettering Health Network at 1 site in United States.
Trial summary
The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-op Pain
- What is being tested?
- Oral acetaminophen and IV acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Able to provide written consent
- Able to read and write in English
- Weighing over 50 kg
- Will undergo total hip or total knee joint replacement
Who cannot join
- Non-verbal patients
- Unable to use numeric pain scale
- Allergic to the test article
- Documented hepatic impairment or failure
- Current illicit drug use
- Requires traumatic or emergent surgery
Show all 11Show fewer
- Pregnant women
- Women who are breastfeeding
- Prisoners
- Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
- Unable to swallow oral capsules
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement
The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen
Read the detailed description
Subjects will be randomized to receive perioperative dosing of either:
- Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR,
- IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules).
Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.
- Conditions
- Post-op Pain
- Being tested
- Oral acetaminophen, IV acetaminophen
- Keywords
- Hip replacement, Knee replacement, randomized trial, acetaminophen, post-op pain management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral acetaminophenDrug
Also called Tylenol
Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.
IV acetaminophenDrug
Also called Ofirmev
Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
| Study group | Role | What they receive |
|---|---|---|
| Oral acetaminophen | Active comparator | Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Receives: Drug: Oral acetaminophen |
| IV acetaminophen | Active comparator | Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. Receives: Drug: IV acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Post-operative Use of Opioids
Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
Measured: During post-op period up to 24 hrs after surgery
Secondary outcomes (1)
Patient-rated Pain in the Post-operative Period
Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.
Measured: Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionApr 2016
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 Post-op 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidney (Skip) Hickman, RPh, Principal investigator, Kettering Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244619
- Sponsor's protocol ID
- KMCPH-13-001
- Acronym
- KHEA
- Status last verified
- Jul 2017
- First submitted
- 16 Sep 2014
- Last updated
- 24 Jul 2017
- 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 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement
- ClinicalTrials.gov ID
- NCT02244619
- Acronym / sponsor ID
- KHEA / KMCPH-13-001
- Conditions
- Post-op Pain
- Keywords
- Hip replacement, Knee replacement, randomized trial, acetaminophen, post-op pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 24 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen
Detailed description
Subjects will be randomized to receive perioperative dosing of either:
- Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR,
- IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules).
Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral acetaminophen | Active comparator | Drug: Oral acetaminophenSubjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. |
| IV acetaminophen | Active comparator | Drug: IV acetaminophenSubjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- Able to provide written consent
- Able to read and write in English
- Weighing over 50 kg
- Will undergo total hip or total knee joint replacement
Key exclusion criteria (11 listed)
- Non-verbal patients
- Unable to use numeric pain scale
- Allergic to the test article
- Documented hepatic impairment or failure
- Current illicit drug use
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 |
|---|---|---|
| Oral acetaminophenAlso: TylenolSubjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity. | Drug | Oral acetaminophen |
| IV acetaminophenAlso: OfirmevSubjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity. | Drug | IV acetaminophen |
Primary outcome
Total Post-operative Use of Opioids
Time frame: During post-op period up to 24 hrs after surgery
Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
1 secondary outcome
Patient-rated Pain in the Post-operative Period
Time frame: Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- 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.
Sidney (Skip) Hickman, RPh principal investigator
Kettering Health Network
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 Oral acetaminophen and IV acetaminophen in people with Post-op Pain, run by Kettering Health Network 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 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 24 Jul 2017. 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 24 Jul 2017). 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?
Total Post-operative Use of Opioids (time frame: During post-op period up to 24 hrs after surgery). 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 24 Jul 2017.