Last updated: May 12, 2023
Sponsor: University of Monastir
Overall Status: Active - Recruiting
Phase
2/3
Condition
Acute Pain
Pain
Treatment
Ketamine
Clinical Study ID
NCT05229055
Intranasal ketamine
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- • Patients who presented to the ED with acute limb trauma pain with a visual analgesicscale (VAS) of 5 or more on a standard 11 point (0-10).
- Pain was considered traumatic if it is reported as appearing immediately afterthe trauma and no anterior pain was described in the same limb.
Exclusion
Exclusion Criteria:
- 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.
Study Design
Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Ketamine
Phase: 2/3
Study Start date:
April 15, 2023
Estimated Completion Date:
December 01, 2025
Study Description
Connect with a study center
university of Monastir
Monastir, 5000
TunisiaActive - Recruiting
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