Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01106846
Recruitment Status : Terminated (Resources not available to complete.)
First Posted : April 20, 2010
Results First Posted : July 20, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Shireen Ahmad, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Pain
Interventions Drug: Group A: Saline Group
Drug: Group B: 1% Ketamine group
Enrollment 22
Recruitment Details Date of recruitment 03/15/2010-02/14/2013.
Pre-assignment Details  
Arm/Group Title Group A: Saline Group Group B: 1% Ketamine Group
Hide Arm/Group Description

Group A: Saline group , infusion of saline intravenously

Group A: Saline Group: Saline continuous infusion

Group B: Infusion of ketamine 1% intravenously

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

Period Title: Overall Study
Started 12 10
Completed 12 9
Not Completed 0 1
Reason Not Completed
Change in surgical procedure             0             1
Arm/Group Title Group A: Saline Group Group B: 1% Ketamine Group Total
Hide Arm/Group Description

Group A: Saline group , infusion of saline intravenously

Group A: Saline Group: Saline continuous infusion

Group B: Infusion of ketamine 1% intravenously

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

Total of all reporting groups
Overall Number of Baseline Participants 12 10 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
10
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 22 participants
45.08  (3.88) 43.12  (6.19) 44.28  (4.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Female
12
 100.0%
10
 100.0%
22
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 10 participants 22 participants
12 10 22
1.Primary Outcome
Title Quality of Recovery Score Post Operative at 24 Hours
Hide Description Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.
Time Frame 24 hours post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: Saline Group Group B: 1% Ketamine Group
Hide Arm/Group Description:

Group A: Saline group , infusion of saline intravenously

Group A: Saline Group: Saline continuous infusion

Group B: Infusion of ketamine 1% intravenously

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

Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: units on scale
191.2  (9.15) 191.1  (11.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A: Saline Group, Group B: 1% Ketamine Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .947
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 1 Hour post operative
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A: Saline Group Group B: 1% Ketamine Group
Hide Arm/Group Description

Group A: Saline group , infusion of saline intravenously

Group A: Saline Group: Saline continuous infusion

Group B: Infusion of ketamine 1% intravenously

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

All-Cause Mortality
Group A: Saline Group Group B: 1% Ketamine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Group A: Saline Group Group B: 1% Ketamine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A: Saline Group Group B: 1% Ketamine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/12 (25.00%)      0/9 (0.00%)    
Gastrointestinal disorders     
Nausea  1 [1]  3/12 (25.00%)  3 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Nausea 60 minutes post operative
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shireen Ahmad, M.D.
Organization: Northwestern University
Phone: 321-472-3585
EMail: sah704@northwestern.edu
Publications:
Layout table for additonal information
Responsible Party: Shireen Ahmad, Northwestern University
ClinicalTrials.gov Identifier: NCT01106846    
Other Study ID Numbers: STU00026695
First Submitted: April 16, 2010
First Posted: April 20, 2010
Results First Submitted: June 18, 2015
Results First Posted: July 20, 2015
Last Update Posted: August 7, 2015