Trial · NCT07894484
Lactium Premedication to Prevent Emergence Agitation
NCT07894484, Phase 3, Recruiting, Tanta University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lactium Premedication to Prevent Emergence Agitation. Trials, record NCT07894484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07894484
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lactium Premedication to Prevent Emergence Agitation
- NCT number
- NCT07894484
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Tanta University
- Conditions
- Lactium, Premedication, Emergence Agitation, Adenotonsillectomy, Dose Finding Study
- Interventions
- Lactium
- First posted
- 2026-10-26
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of emergence agitation. The dose of lactium that is required to prevent the occurrence of emergence agitation in 90% of children (ED90) will be the primary aim of this study. | Up to 1 hour after surgery | Pediatric Anesthesia Emergence Delirium scale will be used and a score \> 10 together with a Delirium-specific score ≥ 6 (in absence of pain) will be considered a diagnostic endpoint for the development of agitation. it will be assessed on arrival to the post-anesthesia care unit and every 15 min thereafter for 1 hour. The estimated dose (ED90) of lactium and its 95% confidence interval will be estimated using the Dixon and Mood method and isotonic regression. |
| Secondary | Postoperative pain | Up to 1 hour after surgery | the Face, Legs, Activity, Cry and Consolability (FLACC) scale or the Faces Pain Scale-Revised or the Numerical Rating Scale will be used to assess the pain degree as applicable for age at post-anesthesia care unit. A pain score more than 3 will be treated with 0.5mcg/kg of IV fentanyl |
| Secondary | Parental separation anxiety | Perioperative | It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale. It 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 score of 1 or 2 was considered as 'acceptable' separation |
| Secondary | The total dose of rescue fentanyl | Up to 1 hour after surgery | A pain score more than 3 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 |
| 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 |
| Secondary | Negative behavior changes | Up to 1 week after surgery. | Post Hospitalization Behavior Questionnaire will be used to evaluate the child's baseline behavior before anesthesia and any negative behavioral changes at 24 hours, 72 hours, and one week postoperatively. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the Post Hospitalization Behavior Questionnaire items in comparison with the pre-anesthesia baseline values. |
| Secondary | Modified Yale preoperative anxiety scale-short form. | Perioperative | Anxiety scores before the administration of the study drug, during parent separation, and during anesthesia induction will be assessed by the modified Yale preoperative anxiety scale-short form. |
| Secondary | Side effects | Up to 1 hour after surgery. | Postoperative nausea and vomiting, hypotension, bradycardia will be recorded |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07894484
GET https://conductscience.org/api/trials/v1/NCT07894484/registered