Trial Outcomes & Findings for Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery (NCT NCT01106846)

Last Updated: 2015-08-07

Results Overview

Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.

Recruitment status

TERMINATED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

24 hours post operative

Results posted on

2015-08-07

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

Participant milestones
Measure	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.
Overall Study STARTED	12	10
Overall Study COMPLETED	12	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal
Measure	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.
Overall Study Change in surgical procedure	0	1

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

Baseline characteristics by cohort
Measure	Group A: Saline Group n=12 Participants Group A: Saline group , infusion of saline intravenously Group A: Saline Group: Saline continuous infusion	Group B: 1% Ketamine Group n=10 Participants Group B: Infusion of ketamine 1% intravenously Group B: 1% Ketamine group: Administration of 1% ketamine intravenously.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	45.08 years STANDARD_DEVIATION 3.88 • n=93 Participants	43.12 years STANDARD_DEVIATION 6.19 • n=4 Participants	44.28 years STANDARD_DEVIATION 4.43 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	12 participants n=93 Participants	10 participants n=4 Participants	22 participants n=27 Participants

Timeframe: 24 hours post operative

Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.

Outcome measures
Measure	Group A: Saline Group n=12 Participants Group A: Saline group , infusion of saline intravenously Group A: Saline Group: Saline continuous infusion	Group B: 1% Ketamine Group n=9 Participants Group B: Infusion of ketamine 1% intravenously Group B: 1% Ketamine group: Administration of 1% ketamine intravenously.
Quality of Recovery Score Post Operative at 24 Hours	191.2 units on scale Standard Deviation 9.15	191.1 units on scale Standard Deviation 11.3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Group A: Saline Group n=12 participants at risk Group A: Saline group , infusion of saline intravenously Group A: Saline Group: Saline continuous infusion	Group B: 1% Ketamine Group n=9 participants at risk Group B: Infusion of ketamine 1% intravenously Group B: 1% Ketamine group: Administration of 1% ketamine intravenously.
Gastrointestinal disorders Nausea	25.0% 3/12 • Number of events 3 • 1 Hour post operative	0.00% 0/9 • 1 Hour post operative

Northwestern University

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