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

Ketamine

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.

Intervention / Treatment

  • Ketamine i.v (DRUG)
    N/A

Condition or Disease

  • Nasal Obstruction

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years to 100 Years
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Apr 01, 2015 ACTUAL
    Primary Completion: Oct 01, 2017 ACTUAL
    Completion Date: Oct 01, 2017 ACTUAL
    Study First Posted: Nov 19, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 01, 2018

    Sponsors / Collaborators

    Lead Sponsor: Western Galilee Hospital-Nahariya
    Responsible Party: N/A

    Location

    Naharia, Israel

    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

    Participant Groups

    • Patients allocated to this arm will receive an iv dose of 0.5 mg/kg body weight ketamine.

    • Patients allocated to this arm will receive an iv dose of 5ml saline as placebo.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 100
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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

    • The data will be collected from the medical file

    Secondary Outcomes
    • Readmission for any reason. one week
    • Duration of hospital stay. one week

    More Details

    NCT Number: NCT02294162
    Other IDs: 0104-14
    Study URL: https://clinicaltrials.gov/study/NCT02294162
    Last updated: Sep 29, 2023