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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Nasal Obstruction

Intervention / Treatment
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* Drug: Ketamine i.v


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5 mg/kg body weight Ketamin<br>Patients allocated to this arm will receive an iv dose of 0.5 mg/kg body weight ketamine. | Drug: Ketamine i.v<br> <br> |
| Placebo Comparator: 5 ml normal saline as placebo<br>Patients allocated to this arm will receive an iv dose of 5ml saline as placebo. | Drug: Ketamine i.v<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain: reduction in severity based on VAS score. | 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 morning of first post operative day | 
| consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively. | The data will be collected from the medical file | the morning of first post operative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission for any reason. |  | one week | 
| Duration of hospital stay. |  | one week |