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Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01149616
Recruitment Status : Terminated (investigators changed jobs, no longer affiliated with institution)
First Posted : June 23, 2010
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Lauren J. Fisher, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Post Operative Pain
Nausea
Interventions Drug: Dexamethasone 8mg iv x1
Drug: placebo
Enrollment 82
Recruitment Details 2010
Pre-assignment Details  
Arm/Group Title Intervention Placebo
Hide Arm/Group Description

Dexamethasone 8mg iv x 1

Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1

placebo

placebo: placebo administered IV x1

Period Title: Overall Study
Started 41 41
Completed 41 41
Not Completed 0 0
Arm/Group Title Intervention Placebo Total
Hide Arm/Group Description

Dexamethasone 8mg iv x 1

Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1

placebo

placebo: placebo administered IV x1

Total of all reporting groups
Overall Number of Baseline Participants 41 41 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
41
 100.0%
41
 100.0%
82
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
Female
15
  36.6%
16
  39.0%
31
  37.8%
Male
26
  63.4%
25
  61.0%
51
  62.2%
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 41 participants 41 participants 82 participants
41 41 82
1.Primary Outcome
Title Post Operative VAS Pain Scale
Hide Description Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:

Dexamethasone 8mg iv x 1

Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1

placebo

placebo: placebo administered IV x1

Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.88  (0.3) 3.73  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Amount of Postop Narcotic Usage
Hide Description Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:
Dexamethasone 8mg iv x 1
placebo: 2 ml normal saline IV x1
Overall Number of Participants Analyzed 41 41
Median (Inter-Quartile Range)
Unit of Measure: number of tablets
1
(1 to 2)
2
(2 to 4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Postop Nausea
Hide Description NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:
Dexamethasone 8mg iv x 1
placebo: 2 ml normal saline IV x1
Overall Number of Participants Analyzed 41 41
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(0 to 0)
0
(0 to 1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments P value was calculated, and threshold for significance calculated at less than or equal to 0.05
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Placebo
Hide Arm/Group Description

Dexamethasone 8mg iv x 1

Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1

placebo

placebo: placebo administered 2 ml normal saline IV x1

All-Cause Mortality
Intervention Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/41 (0.00%) 
Hide Serious Adverse Events
Intervention Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/41 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/41 (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: Dr Lauren Fisher
Organization: Beth Israel Deaconess Medical Center
Phone: 6176671853
EMail: lauren_fisher@dmgaz.org
Layout table for additonal information
Responsible Party: Lauren J. Fisher, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01149616    
Other Study ID Numbers: 2009P000345
First Submitted: June 22, 2010
First Posted: June 23, 2010
Results First Submitted: March 1, 2017
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017