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Effect of Ketamine Addition to Lidocaine in Rhinoplasty

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ClinicalTrials.gov Identifier: NCT01827020
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
Mukadder Sanli, Inonu University

Tracking Information
First Submitted Date  ICMJE March 28, 2013
First Posted Date  ICMJE April 9, 2013
Last Update Posted Date April 9, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
Postoperative pain scores on the Visual Analogue Scale [ Time Frame: 24 hours ]
Pain scores will examine with Visual analogue scale (VAS, 0-100) in the first 24 hours of postoperative period. The examination will repeated in different time period(5.min, 15.min, 30.min, 1 h, 2h,4.h, 6.h, 8.h, 16.h, 24.h). Patients that have VAS>40 will receive 1mg/kg tramadol.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
  • Patient satisfaction [ Time Frame: 24 hour ]
    At the end of postoperative 24 h, the patient satisfaction will examine by a score as (1 poor, 2 middle, 3 good, 4 perfect)
  • Analgesic demand [ Time Frame: 24 hour ]
    At the first day of postoperative period, analgesic requirement will record. When Visual analogue scale > 40, intravenous 1 mg/kg tramadol bolus will give.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 8, 2013)
Number of participants with adverse effects as a measure of safety and tolerability [ Time Frame: 24 hour ]
Sedation, nausea and vomiting, dizziness, and hallucination will examine as an adverse effect in all patients.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Ketamine Addition to Lidocaine in Rhinoplasty
Official Title  ICMJE Effect of Ketamine Addition to Lidocaine for Postoperative Pain Management in Rhinoplasty
Brief Summary The purpose of this study is to determine whether subanesthetic ketamine addition to lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.
Detailed Description In rhinoplasty operations local infiltration anesthesia uses for surgery insight and patient comfort. The investigators designed this study to prolonged the time of infiltration block and preventive analgesia. So, before operation, study drugs will infiltrate to the submucosa of intranasal cavity. Then, surgeon and patient satisfaction, postoperative analgesic demand, postoperative pain scores and side effects will determine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nose Deformities, Acquired
Intervention  ICMJE
  • Drug: Lidocaine 2 %
    12 mL lidocaine 2% 1mg/kg
    Other Name: preincisional infiltration of lidocaine
  • Drug: Ketamine plus Lidocaine
    ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL
    Other Name: preincisional infiltration of ketamine plus lidocaine
  • Drug: Saline
    12 mL saline (0.9% isotonic solution)
    Other Name: preincisional infiltration of saline
Study Arms  ICMJE
  • Active Comparator: Group L (number of participants=30)
    After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL lidocaine 2%, 1mg/kg into nasal cavity.
    Intervention: Drug: Lidocaine 2 %
  • Active Comparator: Group K (number of participants=30)
    After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL ketamine 0.5 mg/kg plus lidocaine 2% 1 mg/kg of the intranasal cavity.
    Intervention: Drug: Ketamine plus Lidocaine
  • Placebo Comparator: Group S (number of participants=30)
    After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of saline 12 mL into intranasal cavity.
    Intervention: Drug: Saline
Publications * Honarmand A, Safavi M, Karaky H. Preincisional administration of intravenous or subcutaneous infiltration of low-dose ketamine suppresses postoperative pain after appendectomy. J Pain Res. 2012;5:1-6. doi: 10.2147/JPR.S26476. Epub 2011 Dec 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2013)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients scheduled for elective rhinoplasty operation under general anesthesia
  • Patients with ASA (American Society of Anesthesiology) class I
  • Patients between 18-50 years old

Exclusion Criteria:

  • Age <18 and >50
  • ASA > II
  • Preexisting neurological or psychiatric illness
  • Systemic diseases (diabetes mellitus, hypertension, coronary heart disease...)
  • Having a history of chronic pain and receiving chronic analgesia therapy
  • Having a history of drug abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01827020
Other Study ID Numbers  ICMJE Mukadder
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mukadder Sanli, Inonu University
Study Sponsor  ICMJE Inonu University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mukadder Sanli, MD Turgut Ozal Medical Center
PRS Account Inonu University
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP