Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Information source: Western Galilee Hospital-Nahariya
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasal Obstruction
Intervention: Ketamine i.v (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Western Galilee Hospital-Nahariya Overall contact:
Ohad Ronen, MD, Phone: 972507887727, Email: ohad.ronen@naharia.health.gov.il
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.
Clinical Details
Official title: Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Pain: reduction in severity based on VAS score.consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively.
Secondary outcome: Readmission for any reason.Duration of hospital stay.
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Ohad Ronen, MD, Phone: 972507887727, Email: ohad.ronen@naharia.health.gov.il
Galillee medical center, Naharia 2210001, Israel; Recruiting
Ohad Ronen, MD, Phone: +972507887727, Email: ohad.ronen@naharia.gov.il
Ohad Ronen, MD, Principal Investigator
Additional Information
Starting date: April 2015
Last updated: June 10, 2015
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