Phase 4
Completed N=140
Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia
Myringotomy
Source: ClinicalTrials.gov NCT01535287 ↗
Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area). — 7; 8 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The investigators are inviting your child to participate in this research study because your child is having myringotomy (putting a tiny incision in the eardrum with or without tube insertion) under general anesthesia.
The purpose of this study is to determine whether a single injection of Dexmedetomidine (study medication) decreases the frequency of awaking from anesthesia frightened or agitated in children having myringotomy surgery as compared to those children who receive placebo (sterile saltwater).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area). |
7; 8 | — |
| SECONDARY Duration of Stay in PACU |
21; 17 | — |
| SECONDARY Respiratory Complications Peri-Operative |
0; 0 | — |
| SECONDARY Hemodynamic Instability |
0; 0 | — |
| SECONDARY Post-Operative Behavioral Disturbances |
9; 10 | — |
| SECONDARY Muscle Pain |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- ASA I or II (American Society of Anesthesiology classification ASA I means patients without systemic disease, ASA II means patients with one controlled systemic medical disease eg: Diabetes, Hypertension.)
- Between the ages of 1 and 10 years
- Undergoing BMT under general anesthesia.
Exclusion Criteria
- ASA III or higher (Patients with 2 or more medical systemic disease that is not under control, eg: uncontrolled Diabetes)
- Congenital diseases
- Coagulation disorders
- Known allergic reaction to dexmedetomidine
- Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal, neurological or endocrine functions
- Severe upper airway infection
- Predicted difficult airway
- Preexisting psychiatric disorders
Data sourced from ClinicalTrials.gov (NCT01535287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.