Comparison of Pain Using CPOT Score With Ketamine vs. Dexmedetomidine in Post-Craniotomy ICU Patients (CPOT-KD)

Universitas Sumatera Utara

Status: Completed

Conditions: Post-craniotomy; Pain Control in ICU; Post-craniotomy Pain Management; Ketamine vs Dexmedetomidine for Pain Relief

Treatments: Drug: Dexmedetomidine; Drug: ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT07254936

50/KEPK/USU/2025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Ketamine for Pain Management

Other group

Description:

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.

Treatment:

Drug: ketamine

Dexmedetomidine for Pain Management

Other group

Description:

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.

Treatment:

Drug: Dexmedetomidine