NCT07254936

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Universitas Sumatera Utara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Post-craniotomy Pain Management
• Post-craniotomy
• Pain Control in ICU
• Ketamine vs Dexmedetomidine for Pain Relief

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: Indonesia