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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;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Participant, Care Provider, 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
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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 
Overall Participants Analyzed 
[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.  

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

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

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


  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
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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


Publications:
1. Wall PD. The prevention of postoperative pain. Pain 1988; 33: 289-90. 2. Katz J. George Washington Crile, anoci-association, and preemptive analgesia. Pain 1993;53: 243-5. 3. McQual HJ. Pre-emptive analgesia. Br J Anaesth 1992;69: 1-3. 4. Moiniche S, Kehlet H, Dahl JB. A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief: the role of timing of analgesia. Anesthesiology 2002;96: 725-41. 5. Katz J. Pre-emptive analgesia: evidence, current status and future directions. Eur J Anaesthesiol Suppl 995;10:8-13. 6. Katz J, McCartney CJ. Update on pre-emptive analgesia. Curr Opin Anesthesiol 2002; 15: 435-41. 7. McCartney et al. A qualitative systematic review of the role of N-Methyl-D-Aspartate receptor antagonists in preventative analgesia. Anesth Analg 2004; 98: 1385-1400. 8. Wu CT, Yeh CC, Yu JC, et al. Pre-incisional epidural ketamine, morphine and bupivacaine combined with epidural and general anesthesia provides pre-emptive analgesia for upper abdominal surgery. Acta Anaesthesiol Scand 2000;44: 63-8.


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