Lactium Versus Midazolam Premedication on Postoperative Negative Behavioral Changes
Effect of Lactium Versus Midazolam Premedication on Postoperative Negative Behavioral Changes in Children Undergoing Adenotonsillectomy: A Randomized Double-blind Placebo-controlled Trial
This prospective randomized double-blind placebo-controlled study will be conducted to compare the effects of preoperative oral lactium and midazolam on the incidence of postoperative negative behavioral changes in young children undergoing adenotonsillectomy.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Pre-anesthetic sedation may reduce postoperative negative behavioral changes. Midazolam, a benzodiazepine receptor agonist, has been used in attempts to improve child cooperation with anesthesia induction, though with reported variation in effectiveness for benefit at the different stages in the pre-, intra-, and postoperative periods. Lactium" is a synthetic derivative of alpha-s1 casein hydrolysate (ACH) containing the alpha-casozepine peptide, which is one of the main components of milk protein. It has been shown to interact with gamma-aminobutyric acid A receptors to provide anxiolytic and anti-stress effects. In this novel study, we hypothesize that the pre-emptive premedication by oral administration of lactium or midazolam can decrease the incidence of negative behavioral changes in children undergoing adenotonsillectomy.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Osama M Rehab, MD
- Número de teléfono: 002 01095210806
- Correo electrónico: osamarehab@med.tanta.edu.eg
Ubicaciones de estudio
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egipto, 31527
- Tanta University Hospitals
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Contacto:
- Osama M Rehab, MD
- Número de teléfono: 002 01095210806
- Correo electrónico: osamarehab@med.tanta.edu.eg
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Children aged 3 to 12 years.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- scheduled for adenotonsillectomy under sevoflurane general anesthesia.
Exclusion Criteria:
- Parents declined to participate in the trial,
- Children with behavioral changes; neurological or psychiatric diseases
- Physical or developmental delay;
- Sedative or anticonvulsant medication;
- Pre-existing renal or cardiovascular disease.
- Allergy to midazolam or lactose.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Lactium group
Cases will receive preoperative lactium (5 mg/kg). Each lentra sachet (containing 150 mg Lactium) will be totally dissolved in 60 ml water and (2 ml/kg) will be given to cases, 2 hours before surgery with a maximum dose of 300 mg. |
cases will receive preoperative lactium, each lentra sachet (containing 150 mg Lactium) will be totally dissolved in 60 ml water and 5 mg/kg (2 ml/kg) will be given to cases, 2 hours before surgery with a maximum dose of 300 mg. Also, they will receive volume matched and flavored matched water 30 minutes before surgery. The cups and the syringes will be opaque. |
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Experimental: Midazolam group
Cases will receive preoperative 0.5 mg/kg oral midazolam (maximum 20 mg), 30 minutes before surgery. |
cases will receive 2 ml/kg of water dissolved into it a sweet- vanilla flavored powder, 2 hours before surgery. Also, 0.5 mg/kg oral midazolam (maximum 20 mg) will be given 30 minutes before surgery. |
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Comparador de placebos: Control group
Cases will receive volume matched flavored solutions at each corresponding time point. |
Cases will receive volume matched and flavored matched oral solution at each corresponding time point. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of negative behavioral changes at 24-h following surgery.
Periodo de tiempo: 24 hours after surgery.
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It will be assessed by a validated Arabic version of the Post Hospitalization Behavior Questionnaire (PHBQ). This is a 27-item questionnaire that was used to evaluate the child's behavior. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the PHBQ items in comparison with the pre-anesthesia baseline values. |
24 hours after surgery.
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of negative behavioral changes at 3, 7, 14, 30 days following surgery.
Periodo de tiempo: Up to 1 month after surgery
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It will be assessed by a validated Arabic version of the Post Hospitalization Behavior Questionnaire (PHBQ). This is a 27-item questionnaire that was used to evaluate the child's behavior. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the PHBQ items in comparison with the pre-anesthesia baseline values. |
Up to 1 month after surgery
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Incidence of emergence delirium.
Periodo de tiempo: Up to 1 hour after surgery.
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It will be evaluated using the Pediatric Anesthesia Emergence Delirium scale (PAED) scale. A score >12 together with a Delirium-specific score ≥ 9 will be considered a diagnostic endpoint for the development of delirium. |
Up to 1 hour after surgery.
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Parent separation anxiety.
Periodo de tiempo: Perioperative.
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It will be assessed at the time of taking the child to the operating theatre by the attending anesthesiologist using the Parent Separation Anxiety Scale (PSAS). (13) The PSAS ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured but not clinging to parents; and 4 signifies crying and clinging to parents. A PSAS score of 1 or 2 was considered as 'acceptable' separation. |
Perioperative.
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Mask acceptance.
Periodo de tiempo: Perioperative.
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The ease of mask acceptance will be graded using the Mask Acceptance Score (MAS) at the time of induction of general anesthesia with sevoflurane. (14) The MAS scale is a 4-point Likert scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A MAS of 1 or 2 was considered 'satisfactory' mask acceptance |
Perioperative.
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Postoperative pain.
Periodo de tiempo: Up to 1 hour after surgery.
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Postoperative pain will be assessed using the Face, Legs, Activity, Cry and Consolability (FLACC) scale at post-anesthesia care unit arrival and every 0.25 hour for 1 hour after surgery. |
Up to 1 hour after surgery.
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Extubation time.
Periodo de tiempo: End of surgery.
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At the end of surgery, the trachea will be extubated with the patient in the lateral position after confirmation that the gag reflex returned |
End of surgery.
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The total dose of rescue propofol.
Periodo de tiempo: Up to 1 hour after surgery.
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Parental contact will be initiated as the first line management od delirium. If the PAED score remains at least 13 with a Delirium-specific score at least 9 despite parental contact, 1 mg/kg IV propofol will be administered. This dose will be repeated after 15 min if the child still agitated. |
Up to 1 hour after surgery.
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The total dose of rescue fentanyl.
Periodo de tiempo: Up to 1 hour after surgery.
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A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl. This dose will be repeated after 15 min if the child still in pain. The total dose of rescue fentanyl will be recorded. |
Up to 1 hour after surgery.
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Anxiety scores.
Periodo de tiempo: Perioperative.
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anxiety scores before the administration of the study drugs and during parent separation and during anesthesia induction will be assessed by the modified Yale preoperative anxiety scale-short form (m-YPAS-SF). |
Perioperative.
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Side effects.
Periodo de tiempo: Up to 1 hour after surgery.
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Postoperative nausea and vomiting, bradycardia, hypotension, respiratory events will be recorded. |
Up to 1 hour after surgery.
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Comportamiento
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Preparaciones farmacéuticas
- Acciones y usos químicos
- Alimento
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Comida y bebidas
- Usos especializados de productos químicos
- Ayudas farmacéuticas
- Benzazepines
- Benzodiacepinas
- Aditivos alimentarios
- Ingredientes alimentarios
- Midazolam
- Agentes saborizantes
Otros números de identificación del estudio
Otros números de identificación del estudio
- 36265PR276/10/26
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The data will be available upon a reasonable request from the corresponding author.
Marco de tiempo para compartir IPD
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Criterios de acceso compartido de IPD
The data will be available upon a reasonable request from the corresponding author.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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