Effects of Cyclooxygenase (COX) 1-2 Inhibitors on Prevention of Rocuronium Injection Pain

Study Overview
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Brief Summary
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Purpose : The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below. 0;No movement response to injection Mild movement response to injection Hand withdrawal response to injection Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room. Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?

Detailed Description
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Purpose : Rocuronium bromide is a painful agent while general anesthesia induction. The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below. 0;No movement response to injection Mild movement response to injection Hand withdrawal response to injection Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room. Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?

Official Title
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Effects of COX 1-2 Inhibitors on Prevention of Rocuronium Injection Pain: Controlled, Randomised, Double Blind Study

Conditions
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Injection Site Irritation

Intervention / Treatment
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* Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)
* Drug: Saline (Isotonic Saline Solution 0.9% )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non allergic to dexketoprofen 18-60 years old American Society of Anesthesiologists(ASA) 1-2-3 70-90 kg weigh Exclusion Criteria: patients with psychiatric and mental problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexketoprofen group,<br>IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in dexketoprofen group were administered intravenous dexketoprofen (50 mg/2ml) and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction | Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)<br>* intravenous dexketoprofen (KETAVEL 50 mg/2 ml)<br>|
| Other: Saline group<br>IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in control group were administered intravenous 2 ml of saline and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction | Drug: Saline (Isotonic Saline Solution 0.9% )<br>* intravenous 2 ml of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The injection pain due to rocuronium | Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on pain due to injection of rocuronium | Withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexketoprofen, pain, rocuronium