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Trial record 65 of 1880 for:    Acetaminophen

IV Acetaminophen for Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT01798316
Recruitment Status : Terminated (Principal Investigator left the institution)
First Posted : February 25, 2013
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Northwell Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Postoperative Pain
Postoperative Nausea
Postoperative Vomiting
Interventions Drug: IV Acetaminophen
Drug: Standard of Care
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Acetaminophen Standard of Care
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IV Acetaminophen administered before PACU admission

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes

Standard of care pain management regimen including opioids

Standard of Care: without IV acetaminophen

Period Title: Overall Study
Started 52 53
Completed 52 53
Not Completed 0 0
Arm/Group Title IV Acetaminophen Standard of Care Total
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IV Acetaminophen administered before PACU admission

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes

Standard of care pain management regimen including opioids

Standard of Care: No IV acetaminophen

Total of all reporting groups
Overall Number of Baseline Participants 52 53 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 53 participants 105 participants
44.6  (13.0) 44.9  (12.3) 44.7  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 105 participants
Female
40
  76.9%
40
  75.5%
80
  76.2%
Male
12
  23.1%
13
  24.5%
25
  23.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 53 participants 105 participants
52 53 105
1.Primary Outcome
Title Number of Participants With Postoperative Nausea and Vomiting (PONV).
Hide Description

Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay.

PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.

Time Frame 4 hours plus/minus 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Standard of Care
Hide Arm/Group Description:

IV Acetaminophen administered on admission to PACU

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care

Standard of care pain management regimen including opioids administered on admission to PACU

No IV Acetaminophen

Overall Number of Participants Analyzed 52 53
Measure Type: Count of Participants
Unit of Measure: Participants
15 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
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Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery.

PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge.

Time Frame Up to two days following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Post-discharge follow up group. Patients not included in analysis were lost to follow up.
Arm/Group Title IV Acetaminophen Standard of Care
Hide Arm/Group Description:

IV Acetaminophen administered on admission to PACU

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care

Standard of care pain management regimen including opioids administered on admission to PACU

No IV acetaminophen

Overall Number of Participants Analyzed 41 40
Measure Type: Count of Participants
Unit of Measure: Participants
4 10
3.Secondary Outcome
Title Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
Hide Description Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.
Time Frame 4 hours plus/minus 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Standard of Care
Hide Arm/Group Description:

IV Acetaminophen administered before PACU admission

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care

Standard of care pain management regimen including opioids administered on admission to PACU

No IV acetaminophen

Overall Number of Participants Analyzed 52 53
Median (Inter-Quartile Range)
Unit of Measure: Units on a numerical rating scale
6
(5 to 8)
6
(4 to 8)
4.Secondary Outcome
Title Patient Satisfaction on a 5 Point Likert Scale
Hide Description Number of patients very satisfied or satisfied with pain and PONV management during hospital stay
Time Frame Up to one week following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Post-discharge follow up group. Patients not included in analysis were lost to follow up.
Arm/Group Title IV Acetaminophen Standard of Care
Hide Arm/Group Description:

IV Acetaminophen administered on admission to PACU

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care

Standard of care pain management regimen including opioids administered on admission to PACU

No IV Acetaminophen

Overall Number of Participants Analyzed 41 40
Measure Type: Count of Participants
Unit of Measure: Participants
38
  92.7%
35
  87.5%
5.Secondary Outcome
Title Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
Hide Description Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities
Time Frame 1 hour following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Standard of Care
Hide Arm/Group Description:

IV Acetaminophen administered before PACU admission

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care

Standard of care pain management regimen including opioids administered on admission to PACU

No IV acetaminophen

Overall Number of Participants Analyzed 52 53
Median (Inter-Quartile Range)
Unit of Measure: Units on a numerical rating scale
3
(0 to 4)
3
(0 to 4)
6.Other Pre-specified Outcome
Title Number of Patients Requiring Rescue Analgesia for Breakthrough Pain
Hide Description Number of patients requiring rescue analgesia medication during first hour of PACU stay
Time Frame 1 hour following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Standard of Care
Hide Arm/Group Description:

IV Acetaminophen administered on admission to PACU

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care

Standard of care pain management regimen including opioids administered on admission to PACU

No IV Acetaminophen

Overall Number of Participants Analyzed 52 53
Measure Type: Count of Participants
Unit of Measure: Participants
28
  53.8%
20
  37.7%
7.Other Pre-specified Outcome
Title Narcotic Use During PACU Stay
Hide Description Narcotic medication administered during PACU stay in morphine milligram equivalents
Time Frame 4 hours plus/minus 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Standard of Care
Hide Arm/Group Description:

IV Acetaminophen administered on admission to PACU

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care

Standard of care pain management regimen including opioids administered on admission to PACU

No IV Acetaminophen

Overall Number of Participants Analyzed 52 53
Mean (95% Confidence Interval)
Unit of Measure: Morphine milligram equivalents
13.3
(8.5 to 18.0)
16.8
(10.3 to 23.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Acetaminophen Standard of Care
Hide Arm/Group Description

IV Acetaminophen administered on admission to PACU

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care

Standard of care pain management regimen including opioids administered on admission to PACU

No IV acetaminophen

All-Cause Mortality
IV Acetaminophen Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Acetaminophen Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
IV Acetaminophen Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   18/52 (34.62%)   23/53 (43.40%) 
Gastrointestinal disorders     
Nausea   10/52 (19.23%)  15/53 (28.30%) 
Vomiting   6/52 (11.54%)  5/53 (9.43%) 
Nervous system disorders     
Drowziness *  0/52 (0.00%)  2/53 (3.77%) 
Headache *  1/52 (1.92%)  0/53 (0.00%) 
Dizziness *  1/52 (1.92%)  1/53 (1.89%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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: Director of Clinical Research, Department of Anesthesiology
Organization: Northwell
Phone: 718-470-7630
EMail: odowling@northwell.edu
Layout table for additonal information
Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01798316     History of Changes
Other Study ID Numbers: 12-0409
IRB #12-409B ( Other Identifier: North Shore-Long Island Jewish Health System )
First Submitted: February 5, 2013
First Posted: February 25, 2013
Results First Submitted: November 18, 2016
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017