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

ConditionsPostoperative PainCesarean Section Pain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorFatima Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elective lower segment cesarean section

American Society of Anesthesiologists (ASA) Physical Status II

Provided informed consent

Disqualifiers

Known drug allergy

Presence of significant comorbidities

Emergency surgery

Documented psychiatric illness

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Low-Dose DexmedetomidineExperimental treatment 2 interventions
Group B: Medium-Dose DexmedetomidineExperimental treatment 2 interventions
Group C: High-Dose DexmedetomidineExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
0-24 hours post-surgery

Secondary outcomes

1

Time to First Rescue Analgesia

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.

Time frame
Continuous monitoring up to 24 hours postoperative
2

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

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.

Time frame
24 hours postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fatima Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov
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