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Trial record 63 of 1890 for:    Acetaminophen

Preoperative IV Versus Oral Acetaminophen

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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Drug: IV Acetaminophen
Drug: PO Acetaminophen
Drug: PO Placebo
Drug: IV Solution Placebo
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Hide Arm/Group Description

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively

IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention

Period Title: Overall Study
Started 60 60
Completed 60 60
Not Completed 0 0
Arm/Group Title Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group Total
Hide Arm/Group Description

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively

IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention

Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
45.37  (15.82) 46.28  (16.84) 45.83  (16.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
37
  61.7%
35
  58.3%
72
  60.0%
Male
23
  38.3%
25
  41.7%
48
  40.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Patient Reported Pain
Hide Description Pain measured from 0 (no pain) to 10 (worst pain)
Time Frame through study visit, less than 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Hide Arm/Group Description:

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively

IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention

Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.12  (3.092) 4.37  (3.226)
2.Secondary Outcome
Title Number of Participants Who Received Opioid Administration in PACU
Hide Description Number of Participants who Received Opioid Administration in PACU
Time Frame through study visit, less than 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Hide Arm/Group Description:

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively

IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention

Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
31
  51.7%
34
  56.7%
3.Secondary Outcome
Title Number of Participants Who Experienced Postoperative Nausea and Vomiting
Hide Description Did patient experience negative effects of pain medication (postoperative nausea and vomiting)
Time Frame through study visit, less than 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Hide Arm/Group Description:

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively

IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention

Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
8
  13.3%
6
  10.0%
4.Secondary Outcome
Title Length of Stay
Hide Description Minutes from entering PACU to end of Phase II
Time Frame through study visit, less than 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Hide Arm/Group Description:

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively

IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention

Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: minutes
88.25  (26.651) 92.88  (29.911)
5.Secondary Outcome
Title Patient Satisfaction
Hide Description Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)
Time Frame up to 2 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Hide Arm/Group Description:

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively

IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention

Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.45  (0.950) 9.77  (0.528)
Time Frame 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Hide Arm/Group Description

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively

IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention

All-Cause Mortality
Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: IV Acetaminophen Group Arm 2: PO Acetaminophen Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nurse Researcher
Organization: TriHealth
Phone: 513-569-6191
EMail: Rachel_Baker2@trihealth.com
Layout table for additonal information
Responsible Party: Rachel Baker, TriHealth Inc.
ClinicalTrials.gov Identifier: NCT03468920     History of Changes
Other Study ID Numbers: 17-114
First Submitted: March 1, 2018
First Posted: March 19, 2018
Results First Submitted: April 12, 2019
Results First Posted: May 7, 2019
Last Update Posted: May 14, 2019