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Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?

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ClinicalTrials.gov Identifier: NCT02294162
Recruitment Status : Withdrawn (Terminated by IRB)
First Posted : November 19, 2014
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ronen Ohad, Western Galilee Hospital-Nahariya

Tracking Information
First Submitted Date  ICMJE November 14, 2014
First Posted Date  ICMJE November 19, 2014
Last Update Posted Date October 3, 2018
Actual Study Start Date  ICMJE April 1, 2015
Actual Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2014)
  • Pain: reduction in severity based on VAS score. [ Time Frame: the morning of first post operative day ]
    The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day
  • consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively. [ Time Frame: the morning of first post operative day ]
    The data will be collected from the medical file
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2014)
  • Readmission for any reason. [ Time Frame: one week ]
  • Duration of hospital stay. [ Time Frame: one week ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Official Title  ICMJE Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Brief Summary Pain is an unpleasant sensory experience associated with actual or potential tissue damage. Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it is the most important factor related to patient discomfort after surgery. Adequate pain management, ideally resulting in the complete absence of postoperative pain, not only provides comfort to patients, but may also contribute to improved healing and a reduction in the incidence of postoperative complications. Inadequate postoperative analgesia has been shown to contribute to adverse outcomes, including, but not limited to, immunosuppression, hyperglycemia, poor rehabilitation, and progression to chronic pain.
Detailed Description

Patients who are scheduled for submucosal resection of nasal septum with or without turbinectomy will be recruited for the study The patients will be will be assigned to either the treatment group who will be administered ketamine prior to the operation or the control group who will receive a normal saline injection, both in identicle syringes.

All patients will be operated on by the same surgoens and by the same method of dissection and hemostasis (2-5 2 ml lidocadrain carpules, monopolar suction-cautery set on 25).

Patients folow-up will be reported in their medical charts. The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day in the otolaryngology - head and neck department

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Nasal Obstruction
Intervention  ICMJE Drug: Ketamine i.v
Study Arms  ICMJE
  • Experimental: 0.5 mg/kg body weight Ketamin
    Patients allocated to this arm will receive an iv dose of 0.5 mg/kg body weight ketamine.
    Intervention: Drug: Ketamine i.v
  • Placebo Comparator: 5 ml normal saline as placebo
    Patients allocated to this arm will receive an iv dose of 5ml saline as placebo.
    Intervention: Drug: Ketamine i.v
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 1, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2014)
50
Actual Study Completion Date  ICMJE October 1, 2017
Actual Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing submucosal resection of nasal septum with or without turbinectomy.
  • Over 18 years of age.
  • ASA (anesthsiology Severity Score) score of 1-2.
  • Signed informed consent by patient or caregiver.

Exclusion Criteria:

  • Allergy to Ketamine
  • Unable/ unwilling to comply with the protocol requirements
  • Pregnancy or breast feeding
  • Chronic use of analgetics
  • History of alcohol and/or drug abuse
  • Previous nasal surgry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02294162
Other Study ID Numbers  ICMJE 0104-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ronen Ohad, Western Galilee Hospital-Nahariya
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Western Galilee Hospital-Nahariya
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Western Galilee Hospital-Nahariya
Verification Date October 2018

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