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Lactium Versus Midazolam Premedication on Postoperative Negative Behavioral Changes

4. november 2026 opdateret af: Osama Rehab, Tanta University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypten, 31527

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 år til 12 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Lactium

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.
Eksperimentel: Midazolam group

Cases will receive preoperative 0.5 mg/kg oral midazolam (maximum 20 mg), 30 minutes before surgery.
Medicin: Midazolam

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.
Placebo komparator: Control group

Cases will receive volume matched flavored solutions at each corresponding time point.
Andet: Flavored oral solution

Cases will receive volume matched and flavored matched oral solution at each corresponding time point.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of negative behavioral changes at 24-h following surgery.
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of negative behavioral changes at 3, 7, 14, 30 days following surgery.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Mask acceptance.
Tidsramme: 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.
Postoperative pain.
Tidsramme: 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.
Extubation time.
Tidsramme: 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.
The total dose of rescue propofol.
Tidsramme: 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.
The total dose of rescue fentanyl.
Tidsramme: 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.
Anxiety scores.
Tidsramme: 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.
Side effects.
Tidsramme: Up to 1 hour after surgery.

Postoperative nausea and vomiting, bradycardia, hypotension, respiratory events will be recorded.
Up to 1 hour after surgery.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tanta University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. november 2026

Primær færdiggørelse (Anslået)

15. maj 2027

Studieafslutning (Anslået)

15. juni 2027

Datoer for studieregistrering

Først indsendt

4. november 2026

Først indsendt, der opfyldte QC-kriterier

4. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 36265PR276/10/26

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available upon a reasonable request from the corresponding author.

IPD-delingstidsramme

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD-delingsadgangskriterier

The data will be available upon a reasonable request from the corresponding author.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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