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Ketamine: Comparison of IV Push vs. IV Drip

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ClinicalTrials.gov Identifier: NCT02363270
Recruitment Status : Completed
First Posted : February 13, 2015
Results First Posted : October 2, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Intervention Procedure: Ketamine
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Push Group IV Drip Group
Hide Arm/Group Description

Ketamine medication given via IV Push. IV Push is the intervention.

Ketamine: IV Push or or IV Drip

Ketamine medication given via IV Drip. IV Drip is the intervention.

Ketamine: IV Push or or IV Drip

Period Title: Overall Study
Started 24 24
Completed 24 24
Not Completed 0 0
Arm/Group Title IV Push Group IV Drip Group Total
Hide Arm/Group Description

Ketamine medication given via IV Push. IV Push is the intervention.

Ketamine: IV Push or or IV Drip

Ketamine medication given via IV Drip. IV Drip is the intervention.

Ketamine: IV Push or or IV Drip

Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
24
 100.0%
48
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
45.25  (15.12) 43.56  (12.32) 44.40  (13.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
15
  62.5%
12
  50.0%
27
  56.3%
Male
9
  37.5%
12
  50.0%
21
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 48 participants
24 24 48
1.Primary Outcome
Title Overall Rate of Feeling Unreality
Hide Description Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA)
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Push Group IV Drip Group
Hide Arm/Group Description:

Ketamine medication given via IV Push. IV Push is the intervention.

Ketamine: IV Push or or IV Drip

Ketamine medication given via IV Drip. IV Drip is the intervention.

Ketamine: IV Push or or IV Drip

Overall Number of Participants Analyzed 24 24
Measure Type: Count of Participants
Unit of Measure: Participants
22
  91.7%
13
  54.2%
Time Frame 120 minutes
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Push Group IV Drip Group
Hide Arm/Group Description

Ketamine medication given via IV Push. IV Push is the intervention.

Ketamine: IV Push or or IV Drip

Ketamine medication given via IV Drip. IV Drip is the intervention.

Ketamine: IV Push or or IV Drip

All-Cause Mortality
IV Push Group IV Drip Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
IV Push Group IV Drip Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IV Push Group IV Drip Group
Affected / at Risk (%) Affected / at Risk (%)
Total   22/24 (91.67%)   13/24 (54.17%) 
Nervous system disorders     
Feeling of Unreality   22/24 (91.67%)  13/24 (54.17%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Sergey Motov
Organization: Maimonides Medical Center
Phone: 718-283-8693
Responsible Party: Antonios Likourezos, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02363270     History of Changes
Other Study ID Numbers: 2014-10-08-MMC
First Submitted: February 9, 2015
First Posted: February 13, 2015
Results First Submitted: March 18, 2017
Results First Posted: October 2, 2017
Last Update Posted: November 22, 2017