Low Dose Ketamine Intra Nasal Traumatology

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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 opioids analgesic agents.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Monastir
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• - 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.