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The aim of this study is to compare the effect of using different doses of ketamine on producing dysphoric reaction.
Our study is a randomized single-blind observational study. In our study, the effect of producing a dysphoric reaction will be observed by administering ketamine at doses of 0.5 mg/kg and 1 mg/kg to two randomly randomized different groups who presented to our hospital and needed interventional sedation analgesia. For this reason, our patients with an indication for interventional sedation and analgesia will be taken to the observation room and their vital values will be monitored. Two different vascular accesses with at least 18 gauge will be obtained from the two extremities. The patients will be randomized and 0.5 mg/kg IV ketamine will be given to the 1st group. The second group will be given 1 mg/kg IV ketamine. Then, the patients will be recorded in terms of blood pressure, pulse and saturation at the 5th minute, 15th minute and 30th minute. We will give iv ketamine to two different patient groups as 0.5 mg per kilogram in the 1st group and 1 mg per kilogram in the 2nd group and we will observe the patients.We scored the patients between +4 and -5 points on the RASS scale. Patients who were sedated to an extent that they could not be awakened were scored as -5, patients who were dangerously agitated +4, and patients who were awake were scored 0. We considered patients who scored +2 on the Richmond agitation sedation scale as having developed a dysphoric reaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The group given 0.5 mg/kg ketamine | In this group we will give 0.5 mg/kg ketamine and we observe for disphoric reaction |
| |
| The group given 1 mg/kg ketamine | In this group we will give 1 mg/kg ketamine and we observe for disphoric reaction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketalar 50 MG/ML Injectable Solution | Drug | Ketamine will be administered to two different groups as 0.5 mg/kg and 1 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| To observe a significant difference between the two doses in terms of producing a dysphoric reaction | We will give iv ketamine to two different patient groups as 0.5 miligram/kilogram in the 1st group and 1 miligram/kilogram in the 2nd group and we will observe the patients.We scored the patients between +4 and -5 points on the Richmond Agitation and Sedation Scale between -5 to +4. Patients who were sedated to an extent that they could not be awakened were scored as -5, patients who were dangerously agitated +4, and patients who were awake were scored 0. We considered patients who scored +2 on the Richmond agitation sedation scale as having developed a dysphoric reaction. | January 2023-August 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of 0.5 mg/kg and 1 mg/kg IV ketamine | We will give iv ketamine to two different patient groups as 0.5 miligram/kilogram in the 1st group and 1 miligram/kilogram in the 2nd group, and and we will evaluate patients in terms of sedation duration and efficacy.We evaluated the efficacy according to whether additional doses were needed, sedation duration, and the ability to perform the procedural procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparision side effect of iv ketamine between 2 different dose group | We will give iv ketamine to two different patient groups as 0.5 miligram/kilogram in the 1st group and 1 miligram/kilogram in the 2nd group, and we will observe the patients in terms of the incidence of side effects.We monitored patients for the following side effects:Hypertension(Defined as a systolic blood pressure (SBP) of 140 mm Hg or more),tachycardia (Heart rate of more than 100 beats per minute),diplopia or nystagmus, nausea and vomiting, respiratory depression (apnea occurring over 10 seconds or oxygen saturation falling below 90%) |
Inclusion Criteria:
Exclusion Criteria:
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Cases with an indication for sedation analgesia, who applied to our emergency department, will be included in our study. Indications for interventional sedation and analgesia: Tube thoracostomy insertion, central venous catheter insertion, fracture/dislocation reduction, skin incision repair, arthrocentesis, lumbar puncture, paracentesis, burn debridement, cardioversion
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| Name | Affiliation | Role |
|---|---|---|
| Kamil Kokulu, M.D. | Aksaray UTRH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Çağrı Türkücü | Aksaray | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| January 2023-August 2023 |
| January 2023-August 2023 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |