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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pain Intensity (CPOT Score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: ketamine (Drug)
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.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Pain Intensity (CPOT Score)
时间窗: 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.
次要结局
- Heart Rate Stability(Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention)
- Systolic Blood Pressure (SBP) Stability(Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention)
- Diastolic Blood Pressure (DBP) Stability(Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention)
研究者
Septani Anugrah Cinditya
Principal Investigator, Study Program Anesthesiology and Intensive Therapy, Universitas Sumatera Utara.
Universitas Sumatera Utara