UnknownPhase 1

Intranasal Ketamine and Midazolam Mixture for Procedural Sedation in Children With Mental Disabilities:

Egypt40 participantsStarted 2019-03-06

Plain-language 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 intravenous route but sometimes inserting venous access is difficult in uncooperative mentally disabled children. Intranasal ketamine+Midazolam can be a needless effective alternative in these vulnerable patients

Who can participate

Age range4 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

change in sedation level after intranasal or intramuscular ketamine midazolam mixture administration.

Timeframe: every 10 minutes through the study till one hour after administration

Trial details

NCT IDNCT03860831

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

Contact for this trial

dean of faculty of medicine, MD

0020224821894 dean@med.asu.edu.eg

View on ClinicalTrials.gov More Procedural Sedation trials