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COMPLETED
NCT07784556
PHASE2

THIS STUDY AIMS TO COMPARE TWO DRUGS KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING SPINAL ANESTHESIA STUDY POPULATION IS PT UNDERGOING C SECTION . DOSE OF KETAMINE IS 0.25mg/kg and That of TRAMAL 0.5mg/kg.

Sponsor: KRL Hospital, Islamabad

View on ClinicalTrials.gov

Summary

This randomized controlled clinical trial compared the efficacy of intravenous ketamine and tramadol in preventing post-spinal anaesthesia shivering among women undergoing elective caesarean section under spinal anaesthesia. Seventy pregnant women aged 18-45 years with ASA physical status II or III were enrolled and randomly assigned to receive either intravenous tramadol (0.5 mg/kg) or intravenous ketamine (0.25 mg/kg) immediately after delivery of the baby. The primary outcome was the prevention of shivering, defined as the absence of shivering throughout the intraoperative period using the bedside shivering assessment score. Secondary outcomes included the onset time of shivering and comparison of efficacy according to age, body mass index (BMI), and ASA physical status. The study found that ketamine was significantly more effective than tramadol in preventing post-spinal anaesthesia shivering in women undergoing caesarean section, with a lower incidence of shivering and higher overall efficacy. These findings suggest that prophylactic low-dose ketamine may be a more effective option than tramadol for reducing spinal anaesthesia-related shivering during caesarean delivery

Official title: COMPARISON BETWEEN KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING C SECTION UNDER SPINAL ANESTHESIA

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-07-15

Completion Date

2025-09-21

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

Tramadol

Single IV dose of tramadol 0.5 mg/kg given immediately after delivery.

DRUG

Ketamine (0.25 mg/kg)

Single intravenous dose of ketamine 0.25 mg/kg administered immediately after delivery of the baby during elective caesarean section under spinal anaesthesia for prevention of post-spinal shivering.

Locations (2)

KRL hospital islamabad

Islamabad, Islamabad, Pakistan

KRL hospital islamabad

Rawalpindi, Punjab Province, Pakistan