Public trial
RBR-8ttw3f Association between Midazolam and Ketamine compared to Midazolam as sedative in Autistic patients that will be…
Date of registration: 09/20/2018 (mm/dd/yyyy)Last approval date : 09/20/2018 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
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Association between Midazolam and Ketamine as preanesthetic medication in patients with Autistic Spetrum Disorder submitted to odontological treatment under general anesthesia
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Associação de Midazolam e Cetamina em comparação com Midazolam como medicação pré-anestésica em portadores do Espectro Autista submetidos à anestesia geral para tratamento odontológico
Trial identification
- UTN code: U1111-1195-3505
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Public title:
en
Association between Midazolam and Ketamine compared to Midazolam as sedative in Autistic patients that will be submitted to odontological treatment under general anesthesia
pt-br
Associação de Midazolam e Cetamia comparada com Midazolam como sedativo em pacientes Autistas que serão submetidos à anestesia geral para tratamento odontológico
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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65117917.1.0000.0035 - CAAE
Issuing authority: Plataforma Brasil
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2.528.034
Issuing authority: Comitê de Ética em Pesquisa do HGG - Hospital Alberto Rassi
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2.047.760
Issuing authority: Comitê de Ética em Pesquisa da UNESP - Faculdade de Medicina de Botucatu
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65117917.1.0000.0035 - CAAE
Sponsors
- Primary sponsor: Hospital Alberto Rassi- HGG
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Secondary sponsor:
- Institution: Hospital Alberto Rassi- HGG
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Supporting source:
- Institution: Hospital Alberto Rassi- HGG
- Institution: Hospital Santa Terezinha
Health conditions
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Health conditions:
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Autistic disorder; periodontal disease; dental caries
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Autismo; doença periodontal; cáries dentárias
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General descriptors for health conditions:
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C07 Stomatognathic diseases
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C07 Doenças estomatognáticas
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C07 Enfermedades estomatognáticas
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C23 Pathological conditions, signs and symptoms
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C23 Condições patológicas, sinais e sintomas
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C23 Condiciones patológicas, signos y síntomas
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Specific descriptors:
Interventions
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Interventions:
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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 300 mg) given 30 minutes before general anesthesia. Active control gorup: 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) given 30 minutes before general anestesia.
pt-br
Grupo experimental: 40 pacientes autistas que serão submetidos a anestesia geral para tratamento odontológico, receberão por via oral Midazolam (0,5 mg/kg, máximo 15 mg), Cetamina (3 mg/kg via oral, máximo 300 mg) administrados 30 minutos antes do início da anestesia geral. Grupo controle ativo: 40 pacientes autistas que serão submetidos a anestesia geral para tratamento odontológico, receberão por via oral Midazolam (0,5 mg/kg, máximo 15 mg) administrado 30 minutos antes do início da anestesia geral.
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Descriptors:
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D03.633.100.079.080.575 Midazolam
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D03.633.100.079.080.575 Midazolam
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D03.633.100.079.080.575 Midazolam
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D02.455.426.392.368.367.652 Ketamine
pt-br
D02.455.426.392.368.367.652 Ketamina
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D02.455.426.392.368.367.652 Ketamina
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 03/01/2018 (mm/dd/yyyy)
- Date last enrollment: 02/28/2020 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 80 - 2 Y 59 Y -
Inclusion criteria:
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Autistic disorder; dental treatment; general anestesia; physical condition ASA I and II
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Transtorno do Espectro Autista; tratamento dentário; anestesia geral; estado físico ASA I e II
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Exclusion criteria:
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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
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Ausência de consentimento; doenças cardiológicas; previsão de via aérea difícil; doença renal; alergia ou reação adversa prévia aos medicamentos do estudo; impossibilidade de administração completa dos medicamentos
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Treatment Parallel 2 Double-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
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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.
pt-br
Maior frequência de graus de sedação maiores no grupo Midazolam associado a Cetamina, do que no grupo Midazolam isolado, avaliado pela escala de Ramsay, trinta minutos após a administração oral dos medicamentos.
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Secondary outcomes:
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Higher frequency of minimum reaction or any reaction of the patient at the moment of venous access before induction of general anestesia.
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Maior frequência de reação mínima ou não reação do paciente no momento da obtenção do acesso venoso antes da indução da anestesia geral.
Contacts
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Public contact
- Full name: Heber de Moraes Penna
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- Address: Avenida Anhaguera, n 6479 setor Oeste
- City: Goiânia / Brazil
- Zip code: 74110-010
- Phone: +5506232099917
- Email: heberpenna@gmail.com
- Affiliation: Hospital Alberto Rassi- HGG
- Full name: Heber de Moraes Penna
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- Address: Rua T-29 nº 875 apto 2803 Setor Bueno
- City: Goiânia / Brazil
- Zip code: 74210-050
- Phone: +5562996878128
- Email: heberpenna@gmail.com
- Affiliation: Heber de Moraes Penna
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Scientific contact
- Full name: Heber de Moraes Penna
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- Address: Avenida Anhaguera, n 6479 setor Oeste
- City: Goiânia / Brazil
- Zip code: 74110-010
- Phone: +5506232099917
- Email: heberpenna@gmail.com
- Affiliation: Hospital Alberto Rassi- HGG
- Full name: Heber de Moraes Penna
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- Address: Rua T-29 nº 875 apto 2803 Setor Bueno
- City: Goiânia / Brazil
- Zip code: 74210-050
- Phone: +5562996878128
- Email: heberpenna@gmail.com
- Affiliation: Heber de Moraes Penna
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Site contact
- Full name: Cáritas Marquez Franco
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- Address: Avenida Anhaguera, n 6479 setor Oeste
- City: Goiânia / Brazil
- Zip code: 74110-010
- Phone: +55-062-32099917
- Email: hgg.cep@idtech.org.br
- Affiliation: Hospital Alberto Rassi- HGG
- Full name: Cáritas Marquez Franco
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- Address: Av. Anhaguera 6479
- City: Goiânia / Brazil
- Zip code: 74110-010
- Phone: (62)32099917
- Email: hgg.cep@idtech.org.br
- Affiliation: Hospital Alberto Rassi- HGG
- Full name: Fabrício Gayer
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- Address: Av. L , 200
- City: Goiânia / Brazil
- Zip code: 74075-030
- Phone: (62)32123066
- Email: santaterezinha@gmail.com
- Affiliation: Hospital Santa Terezinha
- Full name: Heber de Moraes Penna
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- Address: Rua T-29 nº 875 apto 2803 Setor Bueno
- City: Goiânia / Brazil
- Zip code: 74210-050
- Phone: +5562996878128
- Email: heberpenna@gmail.com
- Affiliation: Heber de Moraes Penna
Additional links:
Total de Ensaios Clínicos 16828.
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