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| ID | Type | Description | Link |
|---|---|---|---|
| 50/KEPK/USU/2025 | Other Identifier | Universitas Sumatera Utara |
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Study Overview:
This study is designed to compare two different medications used to manage pain after craniotomy surgery in the ICU. Craniotomy patients often experience severe pain, and it can be challenging to assess pain in patients who are unable to communicate. We are comparing the effectiveness of ketamine and dexmedetomidine in reducing pain, using the Critical Care Pain Observation Tool (CPOT) score to measure pain levels at different times after surgery.
Objective:
The goal is to determine which of these medications provides better pain relief for post-craniotomy patients in the ICU.
Study Design:
This study is a randomized controlled trial, meaning participants are randomly assigned to receive either ketamine or dexmedetomidine. The trial is single-blinded, which means the doctors administering the treatment will not know which medication the patient is receiving.
Why This Study is Important:
Managing pain effectively after surgery is crucial for recovery. Ketamine is known for its strong pain-relieving properties, while dexmedetomidine provides sedation without affecting breathing. This study will help doctors understand which medication is more effective in reducing pain for post-craniotomy patients.
In this study, we will enroll post-craniotomy patients who are admitted to the ICU. They will be randomly assigned to one of two treatment groups: one group will receive ketamine, and the other will receive dexmedetomidine. Both groups will be given standard pain medication (ketorolac) along with their assigned intervention.
We will measure pain using the Critical Care Pain Observation Tool (CPOT), which evaluates pain based on observable signs such as facial expressions and body movements. CPOT scores will be recorded at several time points: 6 hours (T1), 12 hours (T2), and 24 hours (T3) after receiving the intervention.
Inclusion Criteria:
Patients over the age of 18
Post-craniotomy patients who are intubated and have a Glasgow Coma Scale (GCS) score between 8 and 15.
Exclusion Criteria:
Patients with hypersensitivity to ketamine or dexmedetomidine
Those with renal failure, heart failure, or hepatic failure
Patients who are unable to provide informed consent
Study Location:
This study will take place in the ICU of three hospitals in Medan: H. Adam Malik General Hospital, Hajj General Hospital, and TK II Putri Hijau Army Hospital.
Data Analysis:
After the data is collected, statistical tests will be conducted to determine whether ketamine or dexmedetomidine provides better pain relief. We will analyze CPOT scores from each group and compare the results at different time points (6, 12, and 24 hours).
This study aims to contribute valuable information to improve pain management strategies for post-craniotomy patients in the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine for Pain Management | Other | This arm will receive ketamine as an analgesic to manage post-craniotomy pain in the ICU. Ketamine will be administered as an initial bolus dose of 0.2 mg/kg, followed by a continuous infusion of 0.1-0.2 mg/kg/h. Pain levels will be monitored using the Critical Care Pain Observation Tool (CPOT) at 6, 12, and 24 hours post-administration. |
|
| Dexmedetomidine for Pain Management | Other | This arm will receive dexmedetomidine as an analgesic to manage post-craniotomy pain in the ICU. Dexmedetomidine will be administered as an initial bolus dose of 1 mcg/kg, followed by a continuous infusion of 0.2-0.7 mcg/kg/h. Pain levels will be monitored using the Critical Care Pain Observation Tool (CPOT) at 6, 12, and 24 hours post-administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug | Ketamine will be administered as a bolus dose of 0.2 mg/kg, followed by a continuous infusion of 0.1-0.2 mg/kg/h for pain management in post-craniotomy ICU patients. Pain levels will be assessed using the Critical Care Pain Observation Tool (CPOT) at 6, 12, and 24 hours post-administration. This intervention aims to evaluate ketamine's effectiveness as an analgesic, providing pain relief while minimizing opioid usage. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (CPOT Score) | The Critical Care Pain Observation Tool (CPOT) will be used to assess pain intensity in post-craniotomy ICU patients. The CPOT scale ranges from 0 to 8, where higher scores indicate more severe pain. Pain assessments will be conducted at three time points: 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention. The primary outcome is the difference in mean CPOT scores between the ketamine and dexmedetomidine groups at each time point. | 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Stability | Mean heart rate (beats per minute) will be recorded at baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention to evaluate cardiovascular stability between ketamine and dexmedetomidine groups. | Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Adam Malik General Hospital, Hajj General Hospital, and TK II Putri Hijau Army Hospital | Medan | North Sumatra | 20155 | Indonesia |
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This is a single-blind randomized controlled trial where participants are randomly assigned to one of two treatment groups. Group A will receive ketamine for pain management, while Group B will receive dexmedetomidine. Both groups will be evaluated for pain intensity using the Critical Care Pain Observation Tool (CPOT) at baseline, 6, 12, and 24 hours post-intervention. This parallel assignment design allows for a direct comparison of the effectiveness of these two analgesics in post-craniotomy ICU patients.
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Masking Description:
In this single-blind study, participants are blinded to the treatment they receive (ketamine vs. dexmedetomidine). The care providers and investigators are aware of the assigned treatment.
|
| Dexmedetomidine | Drug | Dexmedetomidine will be administered as a bolus dose of 1 mcg/kg, followed by a continuous infusion of 0.2-0.7 mcg/kg/h for pain management in post-craniotomy ICU patients. Pain levels will be assessed using the Critical Care Pain Observation Tool (CPOT) at 6, 12, and 24 hours post-administration. This intervention aims to evaluate dexmedetomidine's effectiveness as an analgesic, offering sedation without respiratory depression. |
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| Systolic Blood Pressure (SBP) Stability |
Mean systolic blood pressure (mmHg) will be recorded at baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention to assess hemodynamic effects of ketamine and dexmedetomidine. |
| Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention |
| Diastolic Blood Pressure (DBP) Stability | Mean diastolic blood pressure (mmHg) will be recorded at baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention to assess the effect of both drugs on vascular tone and perfusion. | Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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