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

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. Identifier: NCT00486902
Recruitment Status : Completed
First Posted : June 15, 2007
Results First Posted : May 6, 2011
Last Update Posted : April 14, 2014
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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

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
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 
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 94   94   188 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   94   94   188 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 34  (3)   34  (3)   34  (3) 
[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

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

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

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

Kashefi P. The benefits of intraoperative small-dose ketamine on postoperative pain after cesarean section. Anesthesiology 2006;104, Supp 1.

Responsible Party: Cynthia Wong, Northwestern University Identifier: NCT00486902     History of Changes
Other Study ID Numbers: 0524-030
First Submitted: June 13, 2007
First Posted: June 15, 2007
Results First Submitted: March 15, 2011
Results First Posted: May 6, 2011
Last Update Posted: April 14, 2014