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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. 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
Information provided by (Responsible Party):
Shireen Ahmad, Northwestern University

Brief Summary:

Hypothesis: The intraoperative administration of ketamine will result in a 30% reduction in opiate requirement following endometrial ablation surgery and the intraoperative administration of ketamine will result in a decreased time to meet discharge criteria in the PACU following endometrial ablation surgery.

The research question is "Does intraoperative administration of ketamine result in decreased postoperative opiate requirement and time to discharge from the postanesthesia recovery unit (PACU) following hysteroscopic endometrial ablation".

Condition or disease Intervention/treatment Phase
Pain Drug: Group A: Saline Group Drug: Group B: 1% Ketamine group Not Applicable

Detailed Description:


Subjects will be recruited up to 21days prior to the day of surgery. After informed consent is obtained, subjects will be randomly assigned to one of two groups:

Group A: Saline group Group B: 1% Ketamine group

A verbal rating scale (VRS) will be used to assess pain preoperatively. The patient will be asked to identify the severity of pain by indicating on a scale of 0-10 where 0 is "no pain" and 10 is "the worst pain imaginable".

Baseline Quality of Recovery will be obtained. (Appendix F)

Subjects will be randomized prior to surgery to either Group A or Group B. The randomization table is computer generated. There is a 50% allocation to each group.


Standard anesthetic monitoring will be used including monitoring of processed EEG including either the bi-spectral index (BIS) or similar standard of care ASA monitor. A standardized intraoperative anesthetic plan will be utilized by the anesthesia personnel. (Appendix A). Study drug will be prepared and labeled in 10mL syringes by research personnel who will not be involved in the study assessments. Study drug will be administered on initial insertion of Novasure® device (Appendix B).


Pain scores in the PACU will be assessed using the VRS upon admission and every 30 minutes thereafter until discharge criteria are met.

Additionally, nausea, vomiting and retching episodes will be recorded using a VRS.

Postoperative analgesic and antiemetic therapy will be standardized and total amounts of these agents will be recorded Assessment of psychomimetic effects including sedation and agitation will be assess postoperatively prior to discharge using the Richmond Agitation/Sedation Scale (Appendix D).

Acute recovery will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS) (Appendix E). A score of 8 or greater will indicate discharge readiness. Time to fulfill discharge criteria will be recorded.

Any other adverse events and medications required will be recorded. These data will be recorded by research personnel who will be blinded to the study group assignments.

Subjects will be contacted by telephone 24 hours after surgery to assess post-discharge quality of recovery (Appendix F).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery
Study Start Date : March 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Group A: Saline group
Group A: Saline group , infusion of saline intravenously
Drug: Group A: Saline Group
Saline continuous infusion
Other Name: Saline

Active Comparator: Group B: 1% Ketamine group
Group B: Infusion of ketamine 1% intravenously
Drug: Group B: 1% Ketamine group
Administration of 1% ketamine intravenously.
Other Name: Ketamine

Primary Outcome Measures :
  1. Quality of Recovery Score Post Operative at 24 Hours [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Gender: Female
  • Age: 18-65 years
  • Non-pregnant, non-lactating
  • Surgery: Outpatient hysteroscopic Novasure® endometrial ablation
  • Language: English speaking
  • Consent: Obtained

Exclusion Criteria:

  • Patient refusal
  • Under 18 or over age 65
  • Non-English Speaking
  • Pregnancy, Breast feeding
  • Hysteroscopic procedures using Thermachoice® ablation device
  • Chronic use or addiction to opiates, sedatives, non-opiate analgesics
  • History of heavy alcohol usage (>4 drinks/day)
  • Significant cardiovascular or pulmonary disease
  • Psychiatric or emotional disorder
  • Allergy to anesthetic agents utilized in the protocol
  • Glaucoma
  • Thyrotoxicosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01106846

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Prentice Women's Hosptial
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Shireen Ahmad, MD Northwestern University

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Responsible Party: Shireen Ahmad, Principal Investigator, Northwestern University Identifier: NCT01106846    
Other Study ID Numbers: STU00026695
First Posted: April 20, 2010    Key Record Dates
Results First Posted: July 20, 2015
Last Update Posted: August 7, 2015
Last Verified: July 2015
Keywords provided by Shireen Ahmad, Northwestern University:
Outpatient surgery
Additional relevant MeSH terms:
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Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action