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
|Condition or disease||Intervention/treatment||Phase|
|Nose Deformities, Acquired||Drug: Lidocaine 2 % Drug: Ketamine plus Lidocaine Drug: Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Ketamine Addition to Lidocaine for Postoperative Pain Management in Rhinoplasty|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||March 2013|
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.
Drug: Lidocaine 2 %
12 mL lidocaine 2% 1mg/kg
Other Name: preincisional infiltration of lidocaine
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.
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
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.
12 mL saline (0.9% isotonic solution)
Other Name: preincisional infiltration of saline
- 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.
- 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.
- 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.
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): NCT01827020
|Turgut Ozal Medical Center|
|Malatya, Turkey, 44315|
|Principal Investigator:||Mukadder Sanli, MD||Turgut Ozal Medical Center|