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

NCT ID: NCT02294162

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2017-10-01

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

Conditions

Nasal Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

0.5 mg/kg body weight Ketamin

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

Group Type: EXPERIMENTAL

Ketamine i.v

Intervention Type: DRUG

5 ml normal saline as placebo

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

Group Type: PLACEBO_COMPARATOR

Ketamine i.v

Intervention Type: DRUG

Interventions

Ketamine i.v

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ronen Ohad

MD,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Galillee medical center

Nahariya, , Israel

Countries

Israel

Other Identifiers

0104-14

Identifier Type: -

Identifier Source: org_study_id