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Association between Midazolam and Ketamine compared to Midazolam as sedative in Autistic patients that will be submitted to odontological treatment under general anesthesia

Association between Midazolam and Ketamine as preanesthetic medication in patients with Autistic Spetrum Disorder submitted to odontological treatment under general anesthesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8ttw3f
Enrollment
Unknown
Registered
2018-09-20
Start date
2018-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic disorder

Interventions

Experimental group: 40 autistic patients that will undergo to dental treatment under general anestesia.They will receive by oral route Midazolam (0,5 mg/kg, maximum 15 mg), Ketamine (3 mg/kg,maximum 3
Drug

Sponsors

Hospital Alberto Rassi- HGG
Lead Sponsor
Hospital Alberto Rassi- HGG
Collaborator

Eligibility

Age
2 Years to 59 Years

Inclusion criteria

Inclusion criteria: Autistic disorder; dental treatment; general anestesia; physical condition ASA I and II

Exclusion criteria

Exclusion criteria: Lack of consent, cardiac diseases, prediction of difficult airway, renal disease, alergy or previous adverse reaction to medications of the study, impossibility to give the medication completely

Design outcomes

Primary

MeasureTime frame
Higher frequency of greater levels of sedation in the midazolam plus cetamine's group than midazolam alone, assessed by Ramsay' Scale, thirty minuts after oral administration of medications.

Secondary

MeasureTime frame
Higher frequency of minimum reaction or any reaction of the patient at the moment of venous access before induction of general anestesia.

Countries

Brazil

Contacts

Public ContactHeber;Heber Penna;Penna

Hospital Alberto Rassi- HGG;Heber de Moraes Penna

heberpenna@gmail.com;heberpenna@gmail.com+5506232099917;+5562996878128

Outcome results

None listed

Source: REBEC (via WHO ICTRP)