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Study aim: Determination of the effect of rectal diclofenac suppository prophylaxis on shivering after cesarean section Design: Study Design: Double-blind randomized controlled trial Two parallel groups (intervention vs placebo) Single-center study Sample Size: 100 total participants (50 per group) Calculated based on: Type I error (α) = 0.05 Power = 80% Expected minimum difference of 25% in post-anesthesia shivering between groups Randomization: Simple randomization method Individual-level randomization (not cluster) Computer-generated random numbers Double-blinding implemented (both patients and post-operative observers are blinded to group allocation) Study Groups: Intervention Group: Receives 100mg rectal diclofenac suppository 10 minutes before surgery Standard anesthesia protocol Control Group: Receives placebo suppository 10 minutes before surgery Same standard anesthesia protocol Settings and conduct: This double-blind randomized controlled trial will be conducted at a single center. The study will involve women aged 18-40 years undergoing cesarean section with ASA status I or II. The operating room temperature will be maintained at 22-24°C throughout the procedures. Participants/Inclusion and exclusion criteria: Inclusion Criteria: Women aged 18-40 years Undergoing cesarean section ASA status I or II Willing to participate in the study Exclusion Criteria: Allergy to diclofenac Cardiovascular disease Hypertension Diabetes Kidney disease Chronic lung disease Liver disease History of alcohol consumption Body temperature below 36°C Body temperature above 38°C Intervention groups: Receives 100mg rectal diclofenac suppository 10 minutes before surgery Main outcome variables: Determination of the effect of rectal diclofenac suppository prophylaxis on shivering after cesarean section
IRCTID: IRCT20241115063724N1
  1. Comparison the effect of Diclofenac NA and hydrocortisone on shivering in patients undergoing cesarean section under spinal anesthesia
  2. Study of low dose intrathecal meperidine on intra- and post-operative shivering in caesarean section under spinal anesthesia:a prospective double-blind, randomized Clinical Trial
  3. The evaluation of the effect of adding Magnesium Sulfate to intrathecal Marcain to control shivering during cesarean section surgery with spinal anesthesia
  4. Studying the effect of intravenous lidocaine on reducing shivering after spinal anesthesia in cesarean section patients referred to Imam Khomeini Hospital in Sari A double-blind clinical trial
  5. Comparison anti shivering effects between two different doses of intrathecal meperidine versus placebo in cesarean section
  6. Comparison study of combined Diclofenac NA and hydrocortisone versus Diclofenac or hydrocortisone on shivering and pain during cesarean section under spinal anesthesia
  7. COMPARISON OF THE EFFECTIVENESS OF NALBUPHINE VERSUS TRAMADOL FOR PREVENTION OF POST SPINAL SHIVERING IN PATIENTS UNDERGOING LOWER LIMB SURGERY AT TERTIARY CARE HOSPITAL, KARACHI
  8. Effect of ِِDiclofenac rectal suppository in Pentazocin intake in pain after cesarean section in patients referred to Shahid Sadougi Hospital
  9. Evaluation of intrathecal dexmedetomidine effect on core body temperature and shivering during spinal anesthesia for cesarean section
  10. A Comparative Study on the Prophylactic Effects of Different Doses of Intravenous Dexamethasone on Shivering in Patients Undergoing Cesarean Section with Spinal Anesthesia
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