Lactium Versus Midazolam Premedication on Postoperative Negative Behavioral Changes
NCT07928947, Phase 2, Phase 3, Not yet recruiting, Tanta University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Lactium Versus Midazolam Premedication on Postoperative Negative Behavioral Changes | ClinicalTrials.gov |
| NCT number | NCT07928947 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 180 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Tanta University | ClinicalTrials.gov |
| Conditions | Lactium, Midazolam, Behavior, Adenotonsillectomy | ClinicalTrials.gov |
| Interventions | Lactium, Midazolam, Flavored oral solution | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of negative behavioral changes at 24-h following surgery. | 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. | ClinicalTrials.gov |
| Secondary | Incidence of negative behavioral changes at 3, 7, 14, 30 days following surgery. | 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. | ClinicalTrials.gov |
| Secondary | Incidence of emergence delirium. | 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. | ClinicalTrials.gov |
| Secondary | Parent separation anxiety. | 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. | ClinicalTrials.gov |
| Secondary | Mask acceptance. | 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 | ClinicalTrials.gov |
| Secondary | Postoperative pain. | 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. | ClinicalTrials.gov |
| Secondary | Extubation time. | 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 | ClinicalTrials.gov |
| Secondary | The total dose of rescue propofol. | 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. | ClinicalTrials.gov |
| Secondary | The total dose of rescue fentanyl. | 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. | ClinicalTrials.gov |
| Secondary | Anxiety scores. | 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). | ClinicalTrials.gov |
| Secondary | Side effects. | Up to 1 hour after surgery. | Postoperative nausea and vomiting, bradycardia, hypotension, respiratory events will be recorded. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)