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

Primary Purpose

Nasal Obstruction

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ketamine i.v
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nasal Obstruction

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Galillee medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

0.5 mg/kg body weight Ketamin

5 ml normal saline as placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively.
The data will be collected from the medical file

Secondary Outcome Measures

Readmission for any reason.
Duration of hospital stay.

Full Information

First Posted
November 14, 2014
Last Updated
October 1, 2018
Sponsor
Western Galilee Hospital-Nahariya
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1. Study Identification

Unique Protocol Identification Number
NCT02294162
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?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Terminated by IRB
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Galilee Hospital-Nahariya

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5 mg/kg body weight Ketamin
Arm Type
Experimental
Arm Description
Patients allocated to this arm will receive an iv dose of 0.5 mg/kg body weight ketamine.
Arm Title
5 ml normal saline as placebo
Arm Type
Placebo Comparator
Arm Description
Patients allocated to this arm will receive an iv dose of 5ml saline as placebo.
Intervention Type
Drug
Intervention Name(s)
Ketamine i.v
Primary Outcome Measure Information:
Title
Pain: reduction in severity based on VAS score.
Description
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
Time Frame
the morning of first post operative day
Title
consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively.
Description
The data will be collected from the medical file
Time Frame
the morning of first post operative day
Secondary Outcome Measure Information:
Title
Readmission for any reason.
Time Frame
one week
Title
Duration of hospital stay.
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Galillee medical center
City
Naharia
ZIP/Postal Code
2210001
Country
Israel

12. IPD Sharing Statement

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

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