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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000666426
Acronym
C-DEXKET Trial
Enrollment
33
Registered
2025-06-24
Start date
2025-05-16
Completion date
2025-08-16
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 ever

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

Sponsors

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

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026