Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an
      additive to bupivacaine in patients undergoing cesarean section .

      Methods:Following Ethics Committee approval and informed patients consent, Ninety patients
      18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal
      anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were
      randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received
      bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group
      (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group
      (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time
      to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level
      , onset of motor block, duration of blockade, hemodynamics variables, the incidence of
      hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen
      (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation,
      dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were
      instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain,
      10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient
      requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for
      post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of
      administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.
    

Detailed description: 
      The patients were randomly allocated to one of three groups of 30 each. The ketamine group
      (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the
      midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and
      the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water
      intrathecally .
    

Intervention name(s): placebo(distilled water; Ketamine; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .; The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally; The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: midazolam; ketamine; intrathecal; pain