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

Western Galilee Hospital-Nahariya

Status: Withdrawn

Conditions: Nasal Obstruction

Treatments: Drug: Ketamine i.v

Study type: Interventional

Funder types: Other

Identifiers

NCT02294162

0104-14

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

0.5 mg/kg body weight Ketamin

Experimental group

Description:

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

Treatment:

Drug: Ketamine i.v

5 ml normal saline as placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Ketamine i.v