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- Sperimentazione clinica NCT07928947
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Osama M Rehab, MD
- Numero di telefono: 002 01095210806
- Email: osamarehab@med.tanta.edu.eg
Luoghi di studio
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egitto, 31527
- Tanta University Hospitals
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Contatto:
- Osama M Rehab, MD
- Numero di telefono: 002 01095210806
- Email: osamarehab@med.tanta.edu.eg
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Comparatore placebo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of negative behavioral changes at 24-h following surgery.
Lasso di tempo: 24 hours after surgery.
|
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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of negative behavioral changes at 3, 7, 14, 30 days following surgery.
Lasso di tempo: Up to 1 month after surgery
|
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
|
|
Incidence of emergence delirium.
Lasso di tempo: Up to 1 hour after surgery.
|
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.
|
|
Parent separation anxiety.
Lasso di tempo: Perioperative.
|
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.
Lasso di tempo: Perioperative.
|
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.
Lasso di tempo: Up to 1 hour after surgery.
|
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.
Lasso di tempo: End of surgery.
|
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.
Lasso di tempo: Up to 1 hour after surgery.
|
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.
Lasso di tempo: Up to 1 hour after surgery.
|
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.
Lasso di tempo: Perioperative.
|
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.
Lasso di tempo: Up to 1 hour after surgery.
|
Postoperative nausea and vomiting, bradycardia, hypotension, respiratory events will be recorded. |
Up to 1 hour after surgery.
|
Collaboratori e investigatori
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Comportamento
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Preparati farmaceutici
- Azioni e usi chimici
- Cibo
- Dieta, cibo e nutrizione
- Fenomeni fisiologici
- Cibo e bevande
- Usi speciali di sostanze chimiche
- Aiuti farmaceutici
- Benzazepine
- Benzodiazepine
- Additivi alimentari
- Ingredienti alimentari
- Midazolam
- Agenti aromatizzanti
Altri numeri di identificazione dello studio
- 36265PR276/10/26
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
The data will be available upon a reasonable request from the corresponding author.
Periodo di condivisione IPD
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Criteri di accesso alla condivisione IPD
The data will be available upon a reasonable request from the corresponding author.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
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