Does a Single Intravenous Dose of Ketamine Reduce the Need for Supplemental Opioids in Post-Cesarean Section Patients?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00486902
First received: June 13, 2007
Last updated: March 17, 2014
Last verified: March 2014
Results First Received: March 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Ketamine Adverse Reaction
Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
Complication of Labor and/or Delivery
Interventions: Drug: Ketamine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at Prentice Women's Hospital between August 2006 and November 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
188 subjects were recruited for the study. 5 subjects in the ketamine group and 3 in the saline group were excluded after randomization but before study drug administration.

Reporting Groups
  Description
Ketamine Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
Placebo Subjects receive IV Saline 20 mL 5 minutes after infant delivery

Participant Flow:   Overall Study
    Ketamine     Placebo  
STARTED     94     94  
COMPLETED     85     89  
NOT COMPLETED     9     5  
Withdrawal by Subject                 1                 2  
decision for postpartum tubal ligation                 3                 1  
spinal anesthetic protocal violation                 1                 1  
Did not meet inclusion criteria                 1                 0  
No toradol due to hemmorhage or allergy                 3                 1  



  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
Ketamine Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
Placebo Subjects receive IV Saline 20 mL 5 minutes after infant delivery
Total Total of all reporting groups

Baseline Measures
    Ketamine     Placebo     Total  
Number of Participants  
[units: participants]
  94     94     188  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     94     94     188  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34  ± 3     34  ± 3     34  ± 3  
Gender  
[units: participants]
     
Female     94     94     188  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     4     8     12  
Not Hispanic or Latino     90     86     176  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     4     1     5  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     6     10  
White     71     76     147  
More than one race     6     6     12  
Unknown or Not Reported     9     5     14  
Region of Enrollment  
[units: participants]
     
United States     94     94     188  



  Outcome Measures
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1.  Primary:   Number of Subjects Requiring Supplemental Analgesia in the First 24 Hours Following Cesarean Delivery   [ Time Frame: 24 hours ]

2.  Secondary:   Verbal Pain Scores (0 to 10) at First Analgesia Request   [ Time Frame: 24 hours ]

3.  Secondary:   Cumulative Hydrocodone/Acetaminophen for Supplemental Analgesia to Treat Breakthrough Pain   [ Time Frame: 72 hours ]

4.  Secondary:   Postoperative Nausea   [ Time Frame: 24 hours ]

5.  Secondary:   Postoperative Vomiting   [ Time Frame: 24 hours ]

6.  Secondary:   Postperative Pruritus   [ Time Frame: 24 hours ]

7.  Secondary:   Disturbing Dreams   [ Time Frame: 72 hours ]

8.  Post-Hoc:   Pain Score (0-10) at 2 Weeks Following Cesarean Delivery   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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. Robert J. McCarthy
Organization: Northwestern University Feinberg School of Medicine
phone: 312-926-9015
e-mail: r-mccarthy@northwestern.edu


Publications:
Kashefi P. The benefits of intraoperative small-dose ketamine on postoperative pain after cesarean section. Anesthesiology 2006;104, Supp 1.
Downing JW, Mahomedy MC, Jeal DE, Allen PJ. Anaesthesia for cesarean section with ketamine. Anaesthesia 1976;31:883-92.


Responsible Party: Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier: NCT00486902     History of Changes
Other Study ID Numbers: 0524-030
Study First Received: June 13, 2007
Results First Received: March 15, 2011
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board