Post-craniotomy Pain ManagementCPOT-KDNCT07254936
Comparison of Pain Using CPOT Score With Ketamine vs. Dexmedetomidine in Post-Craniotomy ICU Patients
A study testing ketamine and Dexmedetomidine in people with Post-craniotomy Pain Management and Post-craniotomy, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-craniotomy Pain Management, Post-craniotomy, Pain Control in ICU
- What is being tested?
- ketamine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older.
- 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).
Who cannot join
- Hypersensitivity to ketamine or dexmedetomidine.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
H. Adam Malik General Hospital, Hajj General Hospital, and TK II Putri Hijau Army Hospital
Medan, North Sumatra, 20155
About this study
Official title: The Comparison of Pain Using the Critical Care Pain Observation Tool Score With the Administration of Analgesic Doses of Ketamine and Dexmedetomidine in Post-Craniotomy Patients in the ICU
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Post-craniotomy Pain Management, Post-craniotomy, Pain Control in ICU, Ketamine vs Dexmedetomidine for Pain Relief
- Being tested
- ketamine, Dexmedetomidine
- Keywords
- CPOT, Post-craniotomy, Pain management, Ketamine, Dexmedetomidin, ICU pain control, Analgesics in ICU, Pain score assessment, Non-opioid analgesics
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
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.
DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ketamine |
| 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention.
Secondary outcomes (3)
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.
Measured: Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention
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.
Measured: 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.
Measured: Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Mar 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-craniotomy Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Septani Anugrah Cinditya, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254936
- Sponsor's protocol ID
- 50/KEPK/USU/2025
- Other IDs
- 50/KEPK/USU/2025
- Acronym
- CPOT-KD
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Pain Using the Critical Care Pain Observation Tool Score With the Administration of Analgesic Doses of Ketamine and Dexmedetomidine in Post-Craniotomy Patients in the ICU
- ClinicalTrials.gov ID
- NCT07254936
- Acronym / sponsor ID
- CPOT-KD / 50/KEPK/USU/2025
- Conditions
- Post-craniotomy Pain Management, Post-craniotomy, Pain Control in ICU, Ketamine vs Dexmedetomidine for Pain Relief
- Keywords
- CPOT, Post-craniotomy, Pain management, Ketamine, Dexmedetomidin, ICU pain control, Analgesics in ICU, Pain score assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketamine for Pain Management | Other | Drug: ketamineThis 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 | Drug: DexmedetomidineThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years and older.
- 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).
Key exclusion criteria (9 listed)
- Hypersensitivity to ketamine or dexmedetomidine.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamineKetamine 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. | Drug | Ketamine for Pain Management |
| DexmedetomidineDexmedetomidine 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. | Drug | Dexmedetomidine for Pain Management |
Primary outcome
Pain Intensity (CPOT Score)
Time frame: 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention.
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.
3 secondary outcomes
Heart Rate Stability
Time frame: Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Systolic Blood Pressure (SBP) Stability
Time frame: Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Diastolic Blood Pressure (DBP) Stability
Time frame: Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine and Dexmedetomidine in people with Post-craniotomy Pain Management and Post-craniotomy, run by Universitas Sumatera Utara at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (CPOT Score) (time frame: 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.