RecruitingPhase 2ACTRN12625000666426

Comparison of different doses of dexmedetomidine combined with ketamine for managing pain after elective caesarean section

Randomized controlled trial comparing three doses of dexmedetomidine combined with fixed-dose ketamine for postoperative pain control following elective lower segment caesarean section under spinal anesthesia


Sponsor

Ahmed Naeem at Department of Anesthesiology, Fatima Memorial Hospital, Lahore

Enrollment

90 participants

Start Date

May 16, 2025

Study Type

Interventional

Conditions

Summary

This study is designed to improve pain relief after cesarean section surgery by comparing three different doses of a medication called dexmedetomidine, which is combined with ketamine. These medications are known to reduce pain and anxiety without the side effects commonly seen with opioids. Women participating in the study will receive one of the three dose combinations after surgery, and their pain levels will be closely monitored for 24 hours. The goal is to identify which dose provides the best pain control with the least need for additional pain medicine. Hypothesis: We believe that higher doses of dexmedetomidine will result in better pain relief after cesarean section when used with ketamine.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria3

  • Pregnant females aged 18–50 years
  • Undergoing elective lower segment caesarean section under subarachnoid (spinal) block
  • Willing to participate and provide informed consent

Exclusion Criteria5

  • Allergy to dexmedetomidine or ketamine
  • Comorbidities (e.g., cardiac disease, epilepsy, COPD, adrenal insufficiency, malignancy)
  • Psychiatric disorders or chronic opioid use
  • Emergency surgeries
  • Indwelling epidural catheter or unmanageable pain levels

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Interventions

Arm A: Dexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr Arm B: Dexmedetomidine 0.3 µg/kg/hr + Ketamine 0.25 mg/kg/hr Arm C: Dexmedetomidine 0.4 µg/kg/hr + Ketamine 0.25 mg/kg/hr Mode of admi

Arm A: Dexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr Arm B: Dexmedetomidine 0.3 µg/kg/hr + Ketamine 0.25 mg/kg/hr Arm C: Dexmedetomidine 0.4 µg/kg/hr + Ketamine 0.25 mg/kg/hr Mode of administration: Intravenous infusion Duration: Postoperative period (up to 24 hours post-surgery) Setting: Postoperative care following elective caesarean section at Fatima Memorial Hospital, Lahore Personnel: Administered by trained anesthesiology staff Standardized co-analgesia: Paracetamol 1g IV every 8 hours; Nalbuphine 0.1 mg/kg IV rescue if VAS >5 Monitoring: VAS score, heart rate, blood pressure, SpO2 at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours


Locations(1)

Punjab, Pakistan

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ACTRN12625000666426