Skip to main content
OpenTrials
Completed

NCT Number: NCT07254936

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-craniotomy Pain Management Agnosia Ketamine vs Dexmedetomidine for Pain Relief Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Control in ICU Pathological Conditions, Signs and Symptoms Perceptual Disorders Post-craniotomy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Adam Malik General Hospital, Hajj General Hospital, and TK II Putri Hijau Army Hospital

Medan, North Sumatra, 20155, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

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

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Heart Rate Stability

    Time frame: Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention

    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.

  2. Systolic Blood Pressure (SBP) Stability

    Time frame: Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention

    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.

  3. Diastolic Blood Pressure (DBP) Stability

    Time frame: Baseline (T0), 6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Universitas Sumatera Utara

Other

Registry information

Official study 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

Acronym: CPOT-KD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.