Trial intelligence / Profile preview

Tramadol vs Tramadol + Ketamine for Shivering in C-Section

NCT06134895Phase 4

Key facts

Status
Unknown
Start
Aug 2023
Primary completion
Nov 2023
Countries
1
Sponsor
Ziauddin University
Modality
Small Molecules
Conditions
postanesthetic shivering (PAS)
01

Overview

Phase 4, randomised, double-blind trial of ketamine in postanesthetic shivering (PAS) (2 arms), sponsored by Ziauddin University. Primary endpoints: Incidence of shivering and Severity of Shivering. Status: unknown.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Tramadol with Ketamine

    Tramadol 0.25mg/Kg + Ketamine 0.25 mg/Kg

  • Tramadol

    Tramadol 0.5mg/kg

03

Who it enrols

Pregnant females aged 18-40 undergoing lower segment caesarean section with ASA physical status I or II. Excludes patients with hypertension, hypo- or hyperthyroidism, cardiopulmonary disease, pre-eclampsia, eclampsia, or initial body temperature >38.0°C or <36.0°C.

04

Endpoints

Primary

  • Incidence of shivering

  • Severity of Shivering

Secondary

  • Time to shivering

  • Complications

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