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Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries

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ClinicalTrials.gov Identifier: NCT02313675
Recruitment Status : Completed
First Posted : December 10, 2014
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
John Fowler, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Postoperative Pain
Carpal Tunnel Release
Distal Radius Fracture
Interventions Drug: Acetaminophen
Drug: Ketorolac Tromethamine
Drug: Saline
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Tylenol IV Toradol IV Tylenol/Toradol Combination Saline
Hide Arm/Group Description

One time intra-operative IV acetaminophen administration

Acetaminophen

One time intra-operative IV ketorolac thromethamine administration

Ketorolac Tromethamine

One time intra-operative IV combination of acetaminophen/ketorolac administration

Acetaminophen

Ketorolac Tromethamine

One time intra-operative 50ml IV normal saline administration

Saline

Period Title: Overall Study
Started 11 11 11 11
Completed 11 11 11 11
Not Completed 0 0 0 0
Arm/Group Title IV Tylenol IV Toradol IV Tylenol/Toradol Combination Saline Total
Hide Arm/Group Description

One time intra-operative IV acetaminophen administration

Acetaminophen

One time intra-operative IV ketorolac thromethamine administration

Ketorolac Tromethamine

One time intra-operative IV combination of acetaminophen/ketorolac administration

Acetaminophen

Ketorolac Tromethamine

One time intra-operative 50ml IV normal saline administration

Saline

Total of all reporting groups
Overall Number of Baseline Participants 11 11 11 11 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 11 participants 11 participants 44 participants
57
(48 to 67)
48
(37 to 58)
43
(32 to 53)
55
(45 to 65)
51
(43 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 11 participants 11 participants 44 participants
Female
8
  72.7%
8
  72.7%
6
  54.5%
6
  54.5%
28
  63.6%
Male
3
  27.3%
3
  27.3%
5
  45.5%
5
  45.5%
16
  36.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Postoperative Pain (Pain Scores From 0-10 Scale)
Hide Description This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Tylenol IV Toradol IV Tylenol/Toradol Combination Saline
Hide Arm/Group Description:

One time intra-operative IV acetaminophen administration

Acetaminophen

One time intra-operative IV ketorolac thromethamine administration

Ketorolac Tromethamine

One time intra-operative IV combination of acetaminophen/ketorolac administration

Acetaminophen

Ketorolac Tromethamine

One time intra-operative 50ml IV normal saline administration

Saline

Overall Number of Participants Analyzed 11 11 11 11
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.0
(1.7 to 2.3)
2.9
(2.6 to 3.2)
2.7
(2.3 to 3.0)
2.0
(1.7 to 2.3)
2.Secondary Outcome
Title Opioid Consumption (Number of Pills Taken)
Hide Description

Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively

Outcome measure reported below is mean number of opioid pills consumed per day.

Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Tylenol IV Toradol IV Tylenol/Toradol Combination Saline
Hide Arm/Group Description:

One time intra-operative IV acetaminophen administration

Acetaminophen

One time intra-operative IV ketorolac thromethamine administration

Ketorolac Tromethamine

One time intra-operative IV combination of acetaminophen/ketorolac administration

Acetaminophen

Ketorolac Tromethamine

One time intra-operative 50ml IV normal saline administration

Saline

Overall Number of Participants Analyzed 11 11 11 11
Mean (Full Range)
Unit of Measure: pills consumed
0.2
(0 to 12)
0.7
(0 to 16)
1.0
(0 to 20)
0.7
(0 to 16)
Time Frame Time frame is 90 days after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Tylenol IV Toradol IV Tylenol/Toradol Combination Saline
Hide Arm/Group Description

One time intra-operative IV acetaminophen administration

Acetaminophen

One time intra-operative IV ketorolac thromethamine administration

Ketorolac Tromethamine

One time intra-operative IV combination of acetaminophen/ketorolac administration

Acetaminophen

Ketorolac Tromethamine

One time intra-operative 50ml IV normal saline administration

Saline

All-Cause Mortality
IV Tylenol IV Toradol IV Tylenol/Toradol Combination Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%)   0/11 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
IV Tylenol IV Toradol IV Tylenol/Toradol Combination Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%)   0/11 (0.00%)   0/11 (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 Tylenol IV Toradol IV Tylenol/Toradol Combination Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%)   0/11 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John R Fowler, MD
Organization: University of Pittsbur
Phone: 412-605-3245
EMail: fowlerjr@upmc.edu
Layout table for additonal information
Responsible Party: John Fowler, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02313675     History of Changes
Other Study ID Numbers: PRO14110464
First Submitted: December 8, 2014
First Posted: December 10, 2014
Results First Submitted: February 20, 2018
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018