Pain, PostoperativePhase 4NCT03468920
Preoperative IV Versus Oral Acetaminophen
A Phase 4 study testing IV Acetaminophen and PO Acetaminophen in people with Pain, Postoperative, run by TriHealth Inc. at 1 site in United States.
Trial summary
The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- IV Acetaminophen and PO Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 12 Apr 2019
- 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 old or older
- Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia
Who cannot join
- Allergy to Acetaminophen
- Lactose intolerance or lactose allergy (placebo capsules contain lactose)
- Hepatic disease
- Having taken a product containing acetaminophen within 6 hours of scheduled surgery time
- Pregnant
- Weight less than 50kg
Show all 9Show fewer
- Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse
- Emergent or on-call procedures
- Inpatient surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
TriHealth, Bethesda Butler Hospital
Cincinnati, Ohio, 45011
About this study
Official title: Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen
The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.
Read the detailed description
This study will use a randomized, double-blind, controlled design with two arms:
Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively
120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.
- Conditions
- Pain, Postoperative
- Being tested
- IV Acetaminophen, PO Acetaminophen, PO Placebo, IV Solution Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
Also called Tylenol
IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
PO AcetaminophenDrug
Also called Tylenol
Acetaminophen PO 1000mg once pre-operatively
PO PlaceboDrug
PO placebo capsule compounded to match PO Acetaminophen capsule
IV Solution PlaceboDrug
Also called IV Normal Saline
This will serve as the placebo for the IV Acetaminophen intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: IV Acetaminophen group | Experimental | Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively Receives: Drug: IV Acetaminophen; Drug: PO Placebo |
| Arm 2: PO Acetaminophen group | Active comparator | Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively Receives: Drug: PO Acetaminophen; Drug: IV Solution Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Pain
Pain measured from 0 (no pain) to 10 (worst pain)
Measured: through study visit, less than 24 hours
Secondary outcomes (4)
Number of Participants Who Received Opioid Administration in PACU
Number of Participants who Received Opioid Administration in PACU
Measured: through study visit, less than 24 hours
Number of Participants Who Experienced Postoperative Nausea and Vomiting
Did patient experience negative effects of pain medication (postoperative nausea and vomiting)
Measured: through study visit, less than 24 hours
Length of Stay
Minutes from entering PACU to end of Phase II
Measured: through study visit, less than 24 hours
Patient Satisfaction
Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)
Measured: up to 2 days 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 Mar 2018
- Study start1 Apr 2018
- Primary completion14 Feb 2019
- Study completion12 Apr 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 Pain, PostoperativeStudies 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
- Model description
- This study will use a randomized, double-blind, placebo controlled design with two arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Baker, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468920
- Sponsor's protocol ID
- 17-114
- Status last verified
- May 2019
- First submitted
- 1 Mar 2018
- Last updated
- 14 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen
- ClinicalTrials.gov ID
- NCT03468920
- Acronym / sponsor ID
- 17-114
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 7 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.
Detailed description
This study will use a randomized, double-blind, controlled design with two arms:
Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively
120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.
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
- This study will use a randomized, double-blind, placebo controlled design with two arms.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: IV Acetaminophen group | Experimental | Drug: IV Acetaminophen, Drug: PO PlaceboPatients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively |
| Arm 2: PO Acetaminophen group | Active comparator | Drug: PO Acetaminophen, Drug: IV Solution PlaceboPatients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old or older
- Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia
Key exclusion criteria (9 listed)
- Allergy to Acetaminophen
- Lactose intolerance or lactose allergy (placebo capsules contain lactose)
- Hepatic disease
- Having taken a product containing acetaminophen within 6 hours of scheduled surgery time
- Pregnant
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: TylenolIV Acetaminophen 1000mg in 100mL normal saline once pre-operatively | Drug | Arm 1: IV Acetaminophen group |
| PO AcetaminophenAlso: TylenolAcetaminophen PO 1000mg once pre-operatively | Drug | Arm 2: PO Acetaminophen group |
| PO PlaceboPO placebo capsule compounded to match PO Acetaminophen capsule | Drug | Arm 1: IV Acetaminophen group |
| IV Solution PlaceboAlso: IV Normal SalineThis will serve as the placebo for the IV Acetaminophen intervention | Drug | Arm 2: PO Acetaminophen group |
Primary outcome
Patient Reported Pain
Time frame: through study visit, less than 24 hours
Pain measured from 0 (no pain) to 10 (worst pain)
4 secondary outcomes
Number of Participants Who Received Opioid Administration in PACU
Time frame: through study visit, less than 24 hours
Number of Participants Who Experienced Postoperative Nausea and Vomiting
Time frame: through study visit, less than 24 hours
Length of Stay
Time frame: through study visit, less than 24 hours
Patient Satisfaction
Time frame: up to 2 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain, Postoperative, run by TriHealth Inc. 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 2 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 14 May 2019. 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 May 2019). 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?
Patient Reported Pain (time frame: through study visit, less than 24 hours). 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 14 May 2019.