Status:
UNKNOWN
Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Post-traumatic Acute Pain in the Emergency Department ( INVESCK )
Lead Sponsor:
University of Monastir
Conditions:
Acute Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Pain is the most common complaint for emergency department (ED) visit. Intranasal ketamine has been shown to provide rapid, well-tolerated, effective analgesia to emergency department (ED) patients wi...
Detailed Description
Materials and methods : Study design It is a randomized, prospective, double blind, controlled, multicentric trial. Study setting and selection of participants : The trial is conducted in three com...
Eligibility Criteria
Inclusion
- • Patients who presented to the ED with acute limb trauma pain with a visual analgesic scale (VAS) of 5 or more on a standard 11 point (0-10).
- Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb.
Exclusion
- Pregnancy/Breastfeeding
- altered mental status (GCS\<15)
- Allergy to ketamine or morphine
- Weight less than 40 kg or greater than 100kg
- Unstable vital signs (systolic blood pressure \<90 or \> 180mmHg, pulse rate\<50 or \>150bpm, and respiration rate \<10 or \>30 breath/min)
- Medical history of acute head or eye injury
- Medical history of seizure
- Medical history of intracranial hypertension,
- Medical history of chronic pain,
- Medical history of severe renal or hepatic insufficiency.
- Medical history of glaucoma
- Alcohol or drug abuse
- Psychiatric illness,
- Recent (4 hours before) analgesic agent use.
Key Trial Info
Start Date :
April 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05229055
Start Date
April 15 2023
End Date
December 1 2025
Last Update
May 15 2023
Active Locations (1)
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1
university of Monastir
Monastir, Tunisia, 5000