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

NCT07254936 | Completed

• 1 other identifier: 50/KEPK/USU/2025
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

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; Non-opioid analgesics

Outcome Measures

Primary Outcomes (1)

• 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.

  6 hours (T1), 12 hours (T2), and 24 hours (T3) post-intervention.

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

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.

Drug: Dexmedetomidine

Interventions

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.

Ketamine for Pain Management

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.

Dexmedetomidine for Pain Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

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

Medan, North Sumatra, 20155, Indonesia

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Study Program Anesthesiology and Intensive Therapy, Universitas Sumatera Utara.

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: November 28, 2025
• Study Start: March 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-09

Locations

ID (1)