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

This study is currently recruiting participants.
Verified February 2013 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Shireen Ahmad, Northwestern University
ClinicalTrials.gov Identifier:
NCT01106846
First received: April 16, 2010
Last updated: February 22, 2013
Last verified: February 2013

April 16, 2010
February 22, 2013
February 2010
June 2014   (final data collection date for primary outcome measure)
Total dose of postoperative opioid [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]
Total dose of opioids will be determined for up to 24 hours post operatively
Same as current
Complete list of historical versions of study NCT01106846 on ClinicalTrials.gov Archive Site
  • Total dose of intraoperative opioid [ Time Frame: intra operative period ] [ Designated as safety issue: No ]
    Total dose of intraoperative opioids used
  • Opiate related side effects: Nausea, vomiting, retching, sedation [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: Yes ]
    Number of opiate related side effects: Nausea, vomiting, retching, sedation
Same as current
Not Provided
Not Provided
 
Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery
Analgesic Effect of Ketamine in Patients Undergoing Hysteroscopic Endometrial Thermal Ablation Surgery

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".

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pain
  • Drug: Saline
    Saline continuous infusion
  • Drug: Ketamine continuous infusion
    Ketamine continuous infusion
  • Placebo Comparator: Group A: Saline group
    Group A: Saline group , infusion of saline
    Intervention: Drug: Saline
  • Active Comparator: Group B: 1% Ketamine group
    Infusion of ketamine
    Intervention: Drug: Ketamine continuous infusion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact: Shireen Ahmad, MD 312-472-0550 sah704@northwestern.edu
United States
 
NCT01106846
STU00026695
No
Shireen Ahmad, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Shireen Ahmad, MD Northwestern University
Northwestern University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP