Comparison of Pain Using CPOT Score With Ketamine vs. Dexmedetomidine in Post-Craniotomy ICU Patients
NCT ID: NCT07254936
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2025-03-01
2025-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Study Groups
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Ketamine for Pain Management
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.
ketamine
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.
Dexmedetomidine for Pain Management
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.
Dexmedetomidine
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.
Interventions
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ketamine
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.
Dexmedetomidine
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.
Eligibility Criteria
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Inclusion Criteria
* Intubated post-craniotomy patients in the ICU.
* Glasgow Coma Scale (GCS) score of 8-15 pre-operatively. Able to provide informed consent (either personally or through family/legal representative).
Exclusion Criteria
* Renal failure (elevated serum creatinine and BUN).
* Heart failure (EF \<40%, elevated BNP/NT-proBNP, abnormal ECG).
* Hepatic failure (elevated AST/ALT, bilirubin, prolonged PT/INR).
* Patients with severe bradycardia, hypotension, or hallucinations due to study drugs.
* Death during the study period.
* New critical illness (e.g., sepsis, stroke).
* Withdrawal of consent by the patient or family.
* Incomplete data or ICU discharge before 24-hour follow-up.
18 Years
ALL
No
Sponsors
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Universitas Sumatera Utara
OTHER
Responsible Party
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Septani Anugrah Cinditya
Principal Investigator, Study Program Anesthesiology and Intensive Therapy, Universitas Sumatera Utara.
Locations
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H. Adam Malik General Hospital, Hajj General Hospital, and TK II Putri Hijau Army Hospital
Medan, North Sumatra, Indonesia
Countries
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Other Identifiers
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50/KEPK/USU/2025
Identifier Type: OTHER
Identifier Source: secondary_id
50/KEPK/USU/2025
Identifier Type: -
Identifier Source: org_study_id