Comparison of Dexmedetomidine + Ketamine for Postoperative Pain in C-Section

NCT07022821 | Recruiting Phase 4

• 1 other identifier: FMH-KETODEX-CS-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare three different doses of dexmedetomidine, when combined with a fixed dose of ketamine, for pain control in women undergoing cesarean section. The goal is to find the most effective combination with the fewest side effects.

Conditions

Postoperative Pain; Cesarean Section Pain

Keywords

Cesarean Pain; Multimodal Analgesia; Spinal Anesthesia; Dexmedetomidine; Ketamine; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Mean Postoperative Pain Score (Visual Analog Scale)

  Pain will be assessed using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain. Visual Analog Scale (VAS) scores will be recorded at 0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.

  0-24 hours post-surgery

Secondary Outcomes (2)

• Time to First Rescue Analgesia

  Continuous monitoring up to 24 hours postoperative

• Total dose of rescue analgesia (Nalbuphine) required within 24 hours

  24 hours postoperative

Study Arms (3)

Low-Dose Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion

Drug: Dexmedetomidine; Drug: ketamine

Medium-Dose Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine 0.3 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion

Drug: Dexmedetomidine; Drug: ketamine

High-Dose Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine 0.4 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion

Drug: Dexmedetomidine; Drug: ketamine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine infusion at one of the following doses: Group A: 0.2 µg/kg/hr Group B: 0.3 µg/kg/hr Group C: 0.4 µg/kg/hr Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period

High-Dose Dexmedetomidine; Low-Dose Dexmedetomidine; Medium-Dose Dexmedetomidine

ketamine DRUG

Ketamine infusion at a fixed dose of 0.25 mg/kg/hr administered in all three groups. Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period

High-Dose Dexmedetomidine; Low-Dose Dexmedetomidine; Medium-Dose Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Elective lower segment cesarean section
• American Society of Anesthesiologists (ASA) Physical Status II
• Provided informed consent

You may not qualify if:

• Known drug allergy
• Presence of significant comorbidities
• Emergency surgery
• Documented psychiatric illness

Sponsors & Collaborators

• Fatima Memorial Hospital: lead

Study Sites (1)

Department of Anesthesiology, Fatima Memorial Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Ahmed Naeem, MBBS

CONTACT

+923114681512; 2505.ahmed@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 15, 2025
• Study Start: May 16, 2025
• Primary Completion: August 16, 2025
• Study Completion: August 31, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication (1 year post study completion)
• Access Criteria: On reasonable request by clinical researchers

Locations

PA (1)