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

Postoperative pain after caesarean section

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

Plain Language Summary

Simplified for easier understanding

Pain after caesarean section can be significant, and managing it well without relying heavily on opioids (which can cause constipation, drowsiness, and other side effects) is an important goal in maternity care. This study is testing three different doses of a combination of two medications — dexmedetomidine and ketamine — to find the dose that provides the best pain relief after caesarean section with the fewest side effects. All participants will have already chosen to have a planned caesarean section under spinal anaesthesia. After surgery, they will receive one of three dose combinations and their pain levels will be closely monitored for 24 hours. Researchers will track how much additional pain medication is needed and how comfortable participants feel. This study is for women aged 18 to 50 who are having an elective lower segment caesarean section under spinal anaesthesia and are willing to participate. Women with heart disease, epilepsy, COPD, psychiatric conditions, or who are having emergency surgery are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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