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NCT Number: NCT07022821

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Fatima Memorial Hospital

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Ahmed Naeem, MBBS

PRINCIPAL_INVESTIGATOR

About this study

Caesarean section is associated with moderate-to-severe postoperative discomfort in a significant proportion of women, which can delay recovery and return to regular activities, disrupt mother-child bonding, affect maternal psychological well-being, and impede nursing. Furthermore, inadequate surgical pain treatment may result in hyperalgesia and chronic pain. Due to widespread misconceptions that analgesic medications or procedures may have detrimental effects on the mother or newborn, and because the severity of post-caesarean section pain is typically underestimated, pain following caesarean section is frequently under-treated.

Various analgesic therapy techniques include oral or parenteral opioids, nonsteroidal anti-inflammatory medications, and neuraxial blocks with or without adjuvants, with unclear efficacy and/or substantial adverse effects. While opioids are the gold standard for postoperative pain management, they are associated with respiratory depression, nausea, vomiting, and other adverse effects that increase patient suffering. In recent years, there has been a shift toward minimizing opioid use and developing guidelines for enhanced postpartum recovery. Studies have explored combining opioids with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), ketamine, clonidine, and dexmedetomidine for effective pain relief while avoiding opioid-related side effects.

Dexmedetomidine, a highly selective α2-agonist, is beneficial in reducing tension and anxiety. It may be effective in the management of postoperative pain due to its analgesic properties. Dexmedetomidine acts at spinal and supraspinal sites, producing antinociceptive effects via stimulation of α2-receptors in the locus coeruleus.

Ketamine has been shown to be an effective painkiller with few side effects when used in small doses. Its analgesic effects result from N-methyl-D-aspartate (NMDA) receptor antagonism, and it also interacts with opioid receptors in the brain and spinal cord. When combined with benzodiazepines, ketamine's adverse effects are further minimized.

The combination of ketamine and dexmedetomidine offers several benefits, including hemodynamic stability, absence of respiratory depression, improved postoperative analgesia, and smoother recovery. Previous work has demonstrated a synergistic effect when these agents are used together, providing excellent symptom relief while minimizing side effects.

This study seeks to address the current gap in literature regarding the comparative efficacy of different doses of dexmedetomidine combined with a fixed dose of ketamine for post-cesarean analgesia. It aims to evaluate three infusion doses of dexmedetomidine combined with ketamine using postoperative pain scores as the primary outcome measure. The findings may help optimize pain management protocols following cesarean section

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

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

Primary outcomes

  1. Mean Postoperative Pain Score (Visual Analog Scale)

    Time frame: 0-24 hours post-surgery

    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.

Secondary outcomes

  1. Time to First Rescue Analgesia

    Time frame: Continuous monitoring up to 24 hours postoperative

    Measured in hours from the end of surgery to the time when the first dose of rescue analgesia (Nalbuphine 0.1 mg/kg Intravenous) is administered. Time will be recorded prospectively by anesthesia staff using standardized postoperative monitoring sheets and confirmed from the medication administration records.

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

    Time frame: 24 hours postoperative

    Determined from direct observation and recorded in structured data collection forms by trained anesthesia personnel during the postoperative period. All doses of Nalbuphine administered will be documented in real-time and verified against the patient's medication administration records and nursing charts.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Naeem, MBBS

CONTACT

[email protected]

+923114681512

Sponsors and collaborators

Lead sponsor

Fatima Memorial Hospital

Other

Registry information

Official study title

Comparison of Different Doses of Dexmedetomidine in Combination With Ketamine for Control of Post-Operative Pain in Lower Segment Caesarean Section Surgeries

Acronym: KETODEX-CS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2025
Registry last updated
Jun 18, 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.

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