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Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting

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ClinicalTrials.gov Identifier: NCT01827475
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Adam Singer, Stony Brook University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Ibuprofen
Drug: Acetaminophen
Drug: Ibuprofen-acetaminophen combination
Enrollment 90
Recruitment Details Patients were recruited from the emergency department over a 1 year period
Pre-assignment Details  
Arm/Group Title Ibuprofen Acetaminophen Ibuprofen-acetaminophen Combination
Hide Arm/Group Description Ibuprofen 800 mg Acetaminophen 1 gm Ibuprofen 800 mg plus acetaminophen 1 gm
Period Title: Overall Study
Started 30 30 30
Completed 30 30 30
Not Completed 0 0 0
Arm/Group Title Ibuprofen Acetaminophen Ibuprofen-acetaminophen Combination Total
Hide Arm/Group Description Ibuprofen 800 mg Acetaminophen 1 gm Ibuprofen 800 mg plus acetaminophen 1 gm Total of all reporting groups
Overall Number of Baseline Participants 30 30 30 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
  93.3%
30
 100.0%
28
  93.3%
86
  95.6%
>=65 years
2
   6.7%
0
   0.0%
2
   6.7%
4
   4.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 30 participants 90 participants
31  (16) 34  (12) 37  (17) 36  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 participants
Female
14
  46.7%
12
  40.0%
15
  50.0%
41
  45.6%
Male
16
  53.3%
18
  60.0%
15
  50.0%
49
  54.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 30 participants 90 participants
30 30 30 90
1.Primary Outcome
Title Pain Severity
Hide Description Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibuprofen Acetaminophen Ibuprofen-acetaminophen Combination
Hide Arm/Group Description:
Ibuprofen 800 mg
Acetaminophen 1 gm
Ibuprofen 800 mg plus acetaminophen 1 gm
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: mm
39
(28 to 50)
43
(33 to 53)
42
(32 to 51)
2.Secondary Outcome
Title Need for Rescue Pain Relief
Hide Description The need for additional analgesics
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibuprofen Acetaminophen Ibuprofen-acetaminophen Combination
Hide Arm/Group Description:
Ibuprofen 800 mg
Acetaminophen 1 gm
Ibuprofen 800 mg plus acetaminophen 1 gm
Overall Number of Participants Analyzed 30 30 30
Measure Type: Number
Unit of Measure: participants
11 10 5
Time Frame 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibuprofen Acetaminophen Ibuprofen-acetaminophen Combination
Hide Arm/Group Description Ibuprofen 800 mg Acetaminophen 1 gm Ibuprofen 800 mg plus acetaminophen 1 gm
All-Cause Mortality
Ibuprofen Acetaminophen Ibuprofen-acetaminophen Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ibuprofen Acetaminophen Ibuprofen-acetaminophen Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ibuprofen Acetaminophen Ibuprofen-acetaminophen Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   0/30 (0.00%)   1/30 (3.33%) 
Gastrointestinal disorders       
abdominal pain * 1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%) 
Nausea * 1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
Small sample size, single center, short follow up
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. Adam Singer
Organization: Emergency Medicine, Stony Brook U
Phone: 631 444 7856
EMail: adam.singer@stonybrook.edu
Layout table for additonal information
Responsible Party: Adam Singer, Stony Brook University
ClinicalTrials.gov Identifier: NCT01827475     History of Changes
Other Study ID Numbers: IRBNet119536
First Submitted: April 4, 2013
First Posted: April 9, 2013
Results First Submitted: April 9, 2013
Results First Posted: December 31, 2014
Last Update Posted: December 31, 2014