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History of Changes for Study: NCT02294162
Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Latest version (submitted October 1, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 18, 2014 None (earliest Version on record)
2 June 10, 2015 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 April 27, 2016 Study Status and Eligibility
4 November 14, 2016 Study Status
5 October 1, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02294162
Submitted Date:  November 18, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 0104-14
Brief Title: Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Official Title: Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2014
Overall Status: Not yet recruiting
Study Start: December 2014
Primary Completion: September 2015 [Anticipated]
Study Completion: December 2015 [Anticipated]
First Submitted: November 14, 2014
First Submitted that
Met QC Criteria:
November 18, 2014
First Posted: November 19, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 18, 2014
Last Update Posted: November 19, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Western Galilee Hospital-Nahariya
Responsible Party: Principal Investigator
Investigator: Ronen Ohad
Official Title: MD,
Affiliation: Western Galilee Hospital-Nahariya
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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

Open or close this module Conditions
Conditions: Nasal Obstruction
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Ohad Ronen, MD
Telephone: 972507887727
Email: ohad.ronen@naharia.health.gov.il
Central Contact Backup: Tatyana Arzumanov, MD
Telephone: 972507887693
Email: Tatyana.Arzumanov@naharia.health.gov.il
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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