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

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.

Study Overview

• Status: Withdrawn
• Conditions: Nasal Obstruction
• Intervention / Treatment: Drug: Ketamine i.v

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Naharia, Israel, 2210001
    • Galillee medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ketamine i.v
Placebo Comparator: 5 ml normal saline as placebo; Patients allocated to this arm will receive an iv dose of 5ml saline as placebo.	Drug: Ketamine i.v

What is the study measuring?

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	Time Frame
Readmission for any reason.	one week
Duration of hospital stay.	one week

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 0104-14