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IV Acetaminophen as an Analgesic Adjunct

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ClinicalTrials.gov Identifier: NCT02621619
Recruitment Status : Completed
First Posted : December 3, 2015
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Andrew Chang, MD, Albany Medical College

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Pain
Interventions Drug: IV acetaminophen + 0.5 mg IV hydromorphone
Drug: Normal saline + 0.5 mg IV hydromorphone
Enrollment 159
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Acetaminophen + 0.5 mg IV Hydromorphone Placebo + 0.5 mg IV Hydromorphone
Hide Arm/Group Description

1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone

Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

Period Title: Overall Study
Started 80 79
Completed 80 79
Not Completed 0 0
Arm/Group Title IV Acetaminophen + 0.5 mg IV Hydromorphone Placebo + 0.5 mg IV Hydromorphone Total
Hide Arm/Group Description

1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone

Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

Total of all reporting groups
Overall Number of Baseline Participants 80 79 159
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 80 participants 79 participants 159 participants
72
(69 to 79)
72
(68 to 77)
72
(69 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 79 participants 159 participants
Female
30
  37.5%
31
  39.2%
61
  38.4%
Male
50
  62.5%
48
  60.8%
98
  61.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 79 participants 159 participants
Hispanic
51
  63.7%
51
  64.6%
102
  64.2%
African American
20
  25.0%
12
  15.2%
32
  20.1%
White
7
   8.8%
13
  16.5%
20
  12.6%
Other
2
   2.5%
3
   3.8%
5
   3.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 80 participants 79 participants 159 participants
80 79 159
Baseline Pain intensity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 79 participants 159 participants
5-7
13
  16.3%
10
  12.7%
23
  14.5%
8
14
  17.5%
24
  30.4%
38
  23.9%
9
14
  17.5%
8
  10.1%
22
  13.8%
10
17
  21.3%
18
  22.8%
35
  22.0%
[1]
Measure Description:

Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).

This baseline measure indicates the number of participants reporting a given NRS score.

Number of patients nauseated before receiving study medication   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 79 participants 159 participants
Yes - Nauseated
34
  42.5%
38
  48.1%
72
  45.3%
No - not nauseated
46
  57.5%
41
  51.9%
87
  54.7%
[1]
Measure Description: Number of patients nauseated due to their condition, whether as a symptom on its own or due to their level of pain. Those experiencing nausea or vomiting at baseline would not be counted with those who experience nausea or vomiting as a side effect of study medication when comparing the effects and side effects of the study medication.
Number of patients vomited before receiving study medication   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 79 participants 159 participants
Yes - Vomited
17
  21.3%
18
  22.8%
35
  22.0%
No - Did not vomit
63
  78.8%
61
  77.2%
124
  78.0%
[1]
Measure Description: Number of patients vomiting due to their condition, whether as a symptom on its own or due to their level of pain. Those experiencing nausea or vomiting at baseline would not be counted with those who experience nausea or vomiting as a side effect of study medication when comparing the effects and side effects of the study medication.
1.Primary Outcome
Title Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
Hide Description

Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).

Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)].

Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given.

Time Frame baseline and 60 minutes after medication was infused
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen + 0.5 mg IV Hydromorphone Placebo + 0.5 mg IV Hydromorphone
Hide Arm/Group Description:

1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone

Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

Overall Number of Participants Analyzed 80 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.8  (3.2) 5.2  (3.0)
2.Secondary Outcome
Title Change in Pain Intensity Over Time
Hide Description

Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).

Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)].

Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes

Time Frame baseline to 5 min, 15 min, 30 min, and 45 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen + 0.5 mg IV Hydromorphone Placebo + 0.5 mg IV Hydromorphone
Hide Arm/Group Description:

1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone

Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

Overall Number of Participants Analyzed 80 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline to 5 minutes 3.4  (2.8) 2.9  (2.4)
Baseline to 15 minutes 4.7  (3.1) 4.0  (2.6)
Baseline to 30 minutes 5.1  (2.9) 4.8  (2.6)
Baseline to 45 minutes 5.5  (2.9) 5.2  (2.8)
Time Frame 60 minutes
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Acetaminophen + 0.5 mg IV Hydromorphone Placebo + 0.5 mg IV Hydromorphone
Hide Arm/Group Description

1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone

Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone

All-Cause Mortality
IV Acetaminophen + 0.5 mg IV Hydromorphone Placebo + 0.5 mg IV Hydromorphone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/79 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
IV Acetaminophen + 0.5 mg IV Hydromorphone Placebo + 0.5 mg IV Hydromorphone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/79 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Acetaminophen + 0.5 mg IV Hydromorphone Placebo + 0.5 mg IV Hydromorphone
Affected / at Risk (%) Affected / at Risk (%)
Total   16/80 (20.00%)   13/79 (16.46%) 
Cardiac disorders     
Heart rate < 50 beats/min   1/80 (1.25%)  0/79 (0.00%) 
Gastrointestinal disorders     
Nausea  [1]  8/46 (17.39%)  8/41 (19.51%) 
Vomiting  [1]  2/46 (4.35%)  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders     
Oxygen saturation < 95%   1/80 (1.25%)  2/79 (2.53%) 
Skin and subcutaneous tissue disorders     
Pruritus   4/80 (5.00%)  1/79 (1.27%) 
Vascular disorders     
Systolic blood pressure < 90 mmHg   0/80 (0.00%)  1/79 (1.27%) 
Indicates events were collected by systematic assessment
[1]
Only includes patients who were neither nauseated or vomiting before receiving study medication. Those with symptoms before medication infusion were not experiencing the symptom as a side effect, and were therefore not included
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: Dr. Andrew Chang
Organization: Albany Medical Center
Phone: 518-262-0042
EMail: changa1@amc.edu
Layout table for additonal information
Responsible Party: Andrew Chang, MD, Albany Medical College
ClinicalTrials.gov Identifier: NCT02621619     History of Changes
Other Study ID Numbers: 2015-5369
7K23AG033100-07 ( U.S. NIH Grant/Contract )
First Submitted: November 21, 2015
First Posted: December 3, 2015
Results First Submitted: September 14, 2018
Results First Posted: November 8, 2018
Last Update Posted: November 8, 2018