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.

NCT07784556 | Completed Phase 2 DMC

• 1 other identifier: Compbketandtramal123
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Post Spinal Shivering

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-Spinal Anesthesia Shivering

  Proportion of patients who developed shivering after spinal anesthesia, graded using the Tsai and Chu shivering scale (0 = no shivering; 1 = piloerection; 2 = visible tremors in one muscle group; 3 = visible tremors in more than one muscle group; 4 = gross tremors of the whole body).

  Within 30 minutes of spinal anesthesia administration

Secondary Outcomes (1)

• Severity of Post-Spinal Anesthesia Shivering

  Within 30 minutes of spinal anesthesia administration

Study Arms (2)

Tramadol Group

ACTIVE COMPARATOR

Participants received intravenous tramadol 0.5 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering.

Drug: Tramadol

Ketamine Group

EXPERIMENTAL

Participants received intravenous ketamine 0.25 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering.

Drug: Ketamine (0.25 mg/kg)

Interventions

Tramadol DRUG

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

Tramadol Group

Ketamine (0.25 mg/kg) DRUG

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.

Ketamine Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA-2 and ASA-3 patients Undergoing Elective C-Section

You may not qualify if:

• ASA-4 and above Emergency C-Section Cases

Sponsors & Collaborators

• KRL Hospital, Islamabad: lead

Study Sites (2)

KRL hospital islamabad

Islamabad, Islamabad, 44000, Pakistan

Location

KRL hospital islamabad

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Links

• Post spinal anesthesia shivering

MeSH Terms

Interventions

Tramadol; Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Amna Raza, MBBS FCPS

  KRL Hospital, Islamabad

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGT Anesthesia

Model Details: Randomized control trial

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start: July 15, 2024
• Primary Completion: August 20, 2025
• Study Completion: September 21, 2025
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)