Status:
COMPLETED
Low Dose Ketamine Intra Nasal Traumatology
Lead Sponsor:
University of Monastir
Conditions:
Trauma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine analgesic agents in patients with moderate to severe pain in the ED in reducing the need for opioid or non o...
Detailed Description
Intranasal ketamine for treatment of acute pain in the emergency department : A randomized controlled trial Introduction : Pain is the most common complaint for emergency department (ED) visits \[1\...
Eligibility Criteria
Inclusion
- The study includes patients aged 18 to 80 years 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 to 10). An informed consent is necessary.
Exclusion
- \- Pregnancy,
- Breast-feeding,
- Altered mental status,
- Allergy to ketamine or morphine or
- Weight less than 46 kg or greater than 115 kg,
- Unstable vital signs (systolic blood pressure \<90 or \>180 mm Hg, pulse rate \<50 or \>150 beats/min, and respiration rate \<10 or \>30 breaths/min),
- Medical history of acute head or eye injury, seizure, intracranial hypertension, chronic pain, severre renal or hepatic insufficiency,
- Alcohol or drug abuse,
- Psychiatric illness,
- Recent (4 hours before) analgesic agent use.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
1102 Patients enrolled
Trial Details
Trial ID
NCT03233035
Start Date
January 1 2018
End Date
December 1 2018
Last Update
July 2 2019
Active Locations (2)
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1
Nouira Samir
Monastir, Emergency Department Monastir, Tunisia 5000, Tunisia, 5000
2
Emergency department of university hospital Fattouma Bourguiba of Monastir
Monastir, Tunisia, 5000