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.

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

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

Study Overview

• Status: Completed
• Conditions: Post Spinal Shivering
• Intervention / Treatment: Drug: Tramadol; Drug: Ketamine (0.25 mg/kg)

Detailed Description

This randomized controlled clinical trial was conducted at Khan Research Laboratory Hospital, Islamabad, from August 2024 to January 2025 after obtaining ethical approval. The objective was to compare the efficacy of intravenous ketamine and intravenous tramadol in preventing shivering among women undergoing elective caesarean section under spinal anaesthesia.

A total of 70 pregnant women aged between 18 and 45 years with ASA physical status II or III and a body mass index between 18 and 35 kg/m² were included after obtaining written informed consent. Patients with contraindications to spinal anaesthesia, significant medical comorbidities, allergy to study drugs, obstetric emergencies, pre-existing bradycardia, hypotension, or refusal to undergo spinal anaesthesia were excluded.

Participants were randomly allocated into two equal groups using a coin-flip randomization method. Standard perioperative preparation and monitoring were performed for all patients. Spinal anaesthesia was administered using hyperbaric bupivacaine through a standard spinal technique. Immediately after delivery of the baby, patients received either intravenous tramadol (0.5 mg/kg) or intravenous ketamine (0.25 mg/kg) according to their assigned study group.

Patients were monitored throughout surgery for the occurrence of shivering using the bedside shivering assessment score. The primary endpoint was efficacy, defined as complete absence of shivering until completion of surgery and wound closure. Secondary outcome measures included the incidence of shivering, onset time of shivering after spinal anaesthesia, and subgroup analyses according to age, BMI, and ASA physical status.

Data were analysed using SPSS version 30. Quantitative variables were summarized using median and interquartile range because data were not normally distributed. Qualitative variables were expressed as frequencies and percentages. Group comparisons were performed using the Chi-square test, Fisher's exact test, and Mann-Whitney U test where appropriate. A p-value of ≤0.05 was considered statistically significant.

The baseline demographic characteristics were comparable between the two groups with respect to age, BMI, and ASA status. The incidence of post-spinal anaesthesia shivering was significantly lower in the ketamine group than in the tramadol group. Patients receiving ketamine demonstrated a substantially higher proportion of successful prevention of shivering compared with those receiving tramadol. Furthermore, the onset of shivering was delayed or absent in most patients receiving ketamine. Stratified analyses according to age, BMI, and ASA classification did not demonstrate any significant influence of these variables on treatment efficacy.

The study findings indicate that prophylactic low-dose intravenous ketamine provides superior protection against post-spinal anaesthesia shivering compared with low-dose intravenous tramadol in women undergoing caesarean section under spinal anaesthesia. These results support the use of ketamine as an effective prophylactic agent for reducing intraoperative shivering in obstetric patients and may contribute to improved maternal comfort.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad
    • Islamabad, Islamabad, Pakistan, 44000
      • KRL hospital islamabad
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 46000
      • KRL hospital islamabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

ASA-4 and above Emergency C-Section Cases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tramadol Group; Participants received intravenous tramadol 0.5 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering.	Drug: Tramadol; Single IV dose of tramadol 0.5 mg/kg given immediately after delivery.
Experimental: Ketamine Group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Post-Spinal Anesthesia Shivering	Severity of shivering graded using the Tsai and Chu scale (0-4) in patients who developed shivering after spinal anesthesia.	Within 30 minutes of spinal anesthesia administration

Collaborators and Investigators

• Sponsor: KRL Hospital, Islamabad
• Investigators: Study Chair: Amna Raza, MBBS FCPS, KRL Hospital, Islamabad

Publications and helpful links

Helpful Links

• Post spinal anesthesia shivering

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): August 20, 2025
• Study Completion (Actual): September 21, 2025

Study Registration Dates

• First Submitted: August 20, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Lipids; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Amines; Alcohols; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Ketamine; Tramadol
• Other Study ID Numbers: Compbketandtramal123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No