Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intra-operative Ketamine Infusions in Opioid-dependent Patients With Chronic Lower Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00899600
First received: May 8, 2009
Last updated: May 3, 2013
Last verified: May 2013
Results First Received: November 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Low Back Pain
Interventions: Drug: Ketamine
Other: Normal saline

  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
The study was conducted over a two-year period (February 2007 to April 2009) at Dartmouth-Hitchcock Medical Center. Approval was obtained from the Committee for Protection of Human Subjects (Lebanon, NH, United States of America). Informed patient consent was obtained from all patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three hundred and one patients were screended. Of these patients, 165 (55%) were eligible for enrollment. Sixty-one percent of eligible patients were randomized to one of the two treatment groups. No patients enrolled in the study were excluded from the primary analysis.

Reporting Groups
  Description
Normal Saline Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
Ketamine No text entered.

Participant Flow:   Overall Study
    Normal Saline     Ketamine  
STARTED     50     52  
COMPLETED     50     52  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Normal Saline Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
Ketamine No text entered.
Total Total of all reporting groups

Baseline Measures
    Normal Saline     Ketamine     Total  
Number of Participants  
[units: participants]
  50     52     102  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     42     40     82  
>=65 years     8     12     20  
Age  
[units: years]
Mean ± Standard Deviation
  51.4  ± 14.4     51.7  ± 14.2     51.6  ± 14.3  
Gender  
[units: participants]
     
Female     22     19     41  
Male     28     33     61  
Region of Enrollment  
[units: participants]
     
United States     50     52     102  



  Outcome Measures

1.  Primary:   Morphine Consumption in the First 48 Hours After Surgery   [ Time Frame: 48 hours ]

2.  Secondary:   Hospital Duration   [ Time Frame: 24 and 48 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Mortality   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Hemodynamic Changes   [ Time Frame: 24 and 48 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Complications Related to Ketamine   [ Time Frame: 24 and 48 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Randy Loftus
Organization: Dartmouth-Hitchcock Medical Center
phone: 6036504642
e-mail: randy.w.loftus@hitchcock.org


No publications provided


Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00899600     History of Changes
Other Study ID Numbers: 100674
Study First Received: May 8, 2009
Results First Received: November 27, 2012
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board