Status:
UNKNOWN
Intranasal Ketamine and Midazolam Mixture for Procedural Sedation in Children With Mental Disabilities:
Lead Sponsor:
Ain Shams University
Conditions:
Procedural Sedation
Eligibility:
All Genders
4-12 years
Phase:
PHASE1
Brief Summary
Ketamine and Midazolam are well known sedative drugs that can be given through different routes such as intravenous, intramuscular, oral, rectal and intranasal route. Anesthetic staff usually prefer i...
Detailed Description
Sedation and analgesia decreases the need for general anesthesia outside the operating room. Intravenous route is the standard way of sedation, but its use can be limited in uncooperative mentally dis...
Eligibility Criteria
Inclusion
- Inclusion criteria of the patients were:
- Mentally affected children (autism,down syndrome and cerebral palsy)
- children who are scheduled for Short procedures (30 minutes or less) under sedation
Exclusion
- parents refusal.
- child cooperation and acceptance of venipuncture or cannula in situ.
- children with known allergy to ketamine or midazolam.
- liver or renal organ dysfunction.
- suspected difficult cannulation.
- congenital heart disease.
- active pulmonary infection or asthma.
- increased intracranial tension or intraocular pressure.
- severe trauma0
- significant nasal discharge or obstruction.
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03860831
Start Date
March 6 2019
End Date
July 1 2019
Last Update
March 8 2019
Active Locations (2)
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1
Sanaa Farag Mahmoud
Cairo, New Cairo, Egypt, 11835
2
Ainshams hospitals
Cairo, Egypt, 11591