Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery

This study has been terminated.
(Resources not available to complete.)
Sponsor:
Information provided by (Responsible Party):
Shireen Ahmad, Northwestern University
ClinicalTrials.gov Identifier:
NCT01106846
First received: April 16, 2010
Last updated: July 20, 2015
Last verified: July 2015
Results First Received: June 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Pain
Interventions: Drug: Group A: Saline Group
Drug: Group B: 1% Ketamine group

  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
Date of recruitment 03/15/2010-02/14/2013.

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
Group A: Saline Group

Group A: Saline group , infusion of saline intravenously

Group A: Saline Group: Saline continuous infusion

Group B: 1% Ketamine Group

Group B: Infusion of ketamine 1% intravenously

Group B: 1% Ketamine group: Administration of 1% ketamine intravenously.


Participant Flow:   Overall Study
    Group A: Saline Group     Group B: 1% Ketamine Group  
STARTED     12     10  
COMPLETED     12     9  
NOT COMPLETED     0     1  
Change in surgical procedure                 0                 1  



  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
Group A: Saline Group

Group A: Saline group , infusion of saline intravenously

Group A: Saline Group: Saline continuous infusion

Group B: 1% Ketamine Group

Group B: Infusion of ketamine 1% intravenously

Group B: 1% Ketamine group: Administration of 1% ketamine intravenously.

Total Total of all reporting groups

Baseline Measures
    Group A: Saline Group     Group B: 1% Ketamine Group     Total  
Number of Participants  
[units: participants]
  12     10     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     10     22  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  45.08  (3.88)     43.12  (6.19)     44.28  (4.43)  
Gender  
[units: participants]
     
Female     12     10     22  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     12     10     22  



  Outcome Measures

1.  Primary:   Quality of Recovery Score Post Operative at 24 Hours   [ Time Frame: 24 hours post operative ]


  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
Study was terminated early.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Shireen Ahmad, M.D.
Organization: Northwestern University
phone: 321-472-3585
e-mail: sah704@northwestern.edu


Publications:


Responsible Party: Shireen Ahmad, Northwestern University
ClinicalTrials.gov Identifier: NCT01106846     History of Changes
Other Study ID Numbers: STU00026695
Study First Received: April 16, 2010
Results First Received: June 18, 2015
Last Updated: July 20, 2015
Health Authority: United States: Institutional Review Board