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Trial record 63 of 1888 for:    ACETAMINOPHEN

Preoperative IV Versus Oral Acetaminophen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03468920
Recruitment Status : Completed
First Posted : March 19, 2018
Results First Posted : May 7, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Rachel Baker, TriHealth Inc.

Tracking Information
First Submitted Date  ICMJE March 1, 2018
First Posted Date  ICMJE March 19, 2018
Results First Submitted Date  ICMJE April 12, 2019
Results First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE April 1, 2018
Actual Primary Completion Date February 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
Patient Reported Pain [ Time Frame: through study visit, less than 24 hours ]
Pain measured from 0 (no pain) to 10 (worst pain)
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
Pain [ Time Frame: through study visit, less than 24 hours ]
Pain measured from 0 (no pain) to 10 (worst pain)
Change History Complete list of historical versions of study NCT03468920 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Number of Participants Who Received Opioid Administration in PACU [ Time Frame: through study visit, less than 24 hours ]
    Number of Participants who Received Opioid Administration in PACU
  • Number of Participants Who Experienced Postoperative Nausea and Vomiting [ Time Frame: through study visit, less than 24 hours ]
    Did patient experience negative effects of pain medication (postoperative nausea and vomiting)
  • Length of Stay [ Time Frame: through study visit, less than 24 hours ]
    Minutes from entering PACU to end of Phase II
  • Patient Satisfaction [ Time Frame: up to 2 days after surgery ]
    Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
  • Opioid Administration [ Time Frame: through study visit, less than 24 hours ]
    Dose of opioid medication administered
  • Side Effects [ Time Frame: through study visit, less than 24 hours ]
    Negative effects of pain medication (postoperative nausea and vomiting, respiratory depression, and need for reversal agents)
  • Length of Stay [ Time Frame: through study visit, less than 24 hours ]
    Length of patient stay
  • Satisfaction [ Time Frame: up to 2 days after surgery ]
    Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative IV Versus Oral Acetaminophen
Official Title  ICMJE Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will use a randomized, double-blind, placebo controlled design with two arms.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Only pharmacy staff will have randomization scheme and be aware of whether patient received oral Acetaminophen with IV placebo OR if the patient received IV Acetaminophen with oral placebo
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: IV Acetaminophen
    IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
    Other Name: Tylenol
  • Drug: PO Acetaminophen
    Acetaminophen PO 1000mg once pre-operatively
    Other Name: Tylenol
  • Drug: PO Placebo
    PO placebo capsule compounded to match PO Acetaminophen capsule
  • Drug: IV Solution Placebo
    This will serve as the placebo for the IV Acetaminophen intervention
    Other Name: IV Normal Saline
Study Arms  ICMJE
  • Experimental: Arm 1: IV Acetaminophen group
    Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
    Interventions:
    • Drug: IV Acetaminophen
    • Drug: PO Placebo
  • Active Comparator: Arm 2: PO Acetaminophen group
    Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
    Interventions:
    • Drug: PO Acetaminophen
    • Drug: IV Solution Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 12, 2019
Actual Primary Completion Date February 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years old or older
  • Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03468920
Other Study ID Numbers  ICMJE 17-114
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rachel Baker, TriHealth Inc.
Study Sponsor  ICMJE TriHealth Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TriHealth Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP