Text Size

Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00793910
First received: November 18, 2008
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
Results First Received: November 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Postoperative Pain
Interventions: Drug: Gabapentin
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gabapentin Gabapentin 300mg taken by mouth thrice daily for 7 days
Placebo placebo (sugar pill) taken by mouth thrice daily for 7 days

Participant Flow:   Overall Study
    Gabapentin     Placebo  
STARTED     53     53  
COMPLETED     48     46  
NOT COMPLETED     5     7  
discarded study pills                 0                 1  
did not pick up medications                 1                 1  
ineligible based on entry criteria                 2                 3  
decided to undergo LASIK instead of PRK                 2                 1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Gabapentin Gabapentin 300mg taken by mouth thrice daily for 7 days
Placebo placebo (sugar pill) taken by mouth thrice daily for 7 days
Total Total of all reporting groups

Baseline Measures
    Gabapentin     Placebo     Total  
Number of Participants  
[units: participants]
 		  48     46     94  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     48     46     94  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  30.7  ± 8     33.2  ± 7.9     31.9  ± 8  
Gender  
[units: participants]
 		     
Female     6     7     13  
Male     42     39     81  
Region of Enrollment  
[units: participants]
 		     
United States     48     46     94  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Level of Pain   [ Time Frame: 2 hours postoperatively ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Level of Pain
Measure Description level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Time Frame 2 hours postoperatively  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake

Reporting Groups
  Description
Gabapentin Gabapentin 300mg taken by mouth thrice daily for 7 days
Placebo placebo (sugar pill) taken by mouth thrice daily for 7 days

Measured Values
    Gabapentin     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  41     41  
Level of Pain  
[units: units on a scale]
Mean ± Standard Deviation 		  3.85  ± 2.05     4.09  ± 2.38  

No statistical analysis provided for Level of Pain



2.  Primary:   Level of Pain   [ Time Frame: day 1 postoperatively ]
  Show Outcome Measure 2

3.  Primary:   Level of Pain   [ Time Frame: 3 days postoperatively ]
  Show Outcome Measure 3

4.  Primary:   Level of Pain   [ Time Frame: 4 days postoperatively ]
  Show Outcome Measure 4

5.  Secondary:   Occurence of Use of Rescue Medication   [ Time Frame: 2 hours to 4 days postoperatively ]
  Show Outcome Measure 5


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Matthew Kuhnle, DO
Organization: Carl R. Darnall Army Medical Center
phone: 216-965-3518
e-mail: matthew.kuhnle@us.army.mil


No publications provided


ClinicalTrials.gov Identifier: NCT00793910     History of Changes
Other Study ID Numbers: WRAMC WU# 08-6960
Study First Received: November 18, 2008
Results First Received: November 21, 2011
Last Updated: January 7, 2013
Health Authority: United States: Federal Government