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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02294162
Recruitment Status : Withdrawn (Terminated by IRB)
First Posted : November 19, 2014
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ronen Ohad, Western Galilee Hospital-Nahariya

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.

Condition or disease Intervention/treatment Phase
Nasal Obstruction Drug: Ketamine i.v Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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



Primary Outcome Measures :
  1. Pain: reduction in severity based on VAS score. [ Time Frame: the morning of first post operative day ]
    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

  2. consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively. [ Time Frame: the morning of first post operative day ]
    The data will be collected from the medical file


Secondary Outcome Measures :
  1. Readmission for any reason. [ Time Frame: one week ]
  2. Duration of hospital stay. [ Time Frame: one week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294162


Locations
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Israel
Galillee medical center
Naharia, Israel, 2210001
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
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Responsible Party: Ronen Ohad, MD,, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT02294162    
Other Study ID Numbers: 0104-14
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action