Clinical trial NCT02294162: Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Official title: Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nasal Obstruction
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2014-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: Pain: reduction in severity based on VAS score.
timeFrame: the morning of first post operative day
measure: consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively.
timeFrame: the morning of first post operative day
Secondary outcomes:
measure: Readmission for any reason.
timeFrame: one week
measure: Duration of hospital stay.
timeFrame: one week
Other outcomes:
Locations:
city: Naharia
country: Israel
facility: Galillee medical center
Study officials:
References: