Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are:
Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects?
How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events?
Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects.
Participants will:
Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam.
Undergo sedation scoring at 15 and 30 minutes after drug administration.
Be assessed for ease of separation from parents and acceptance of anesthesia mask.
Be monitored for vital signs, recovery times, and any perioperative adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine + Midazolam 0.4 mg/kg | Experimental |
| |
| Dexmedetomidine + Midazolam 0.2 mg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine + Midazolam 0.4 mg/kg | Drug | Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.4 mg/kg, administered 30 minutes before the induction of general anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Mask Acceptance Score (MAS) at time of induction | Mask acceptance will be assessed at the time of anesthesia induction using the Mask Acceptance Score (MAS). A score of 1 or 2 will be considered satisfactory (excellent/good), while scores of 3 or 4 will be considered unsatisfactory. The percentage of children with satisfactory mask acceptance will be compared between groups. | At the time of induction (approximately 30 minutes after premedication) |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Level (MOASS) at 15 and 30 minutes after premedication | Sedation will be evaluated using the Modified Observer's Assessment of Alertness/Sedation Scale (MOASS). Scores will be recorded at 15 and 30 minutes after intranasal drug administration. | 15 minutes and 30 minutes after drug administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed AEH Ellhwany | Contact | +201013890313 | ahmed.abdalaty2009@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al-Ainy Hospital, Cairo University | Cairo | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21751690 | Background | Mountain BW, Smithson L, Cramolini M, Wyatt TH, Newman M. Dexmedetomidine as a pediatric anesthetic premedication to reduce anxiety and to deter emergence delirium. AANA J. 2011 Jun;79(3):219-24. | |
| 17681185 | Background | Cohen LB, Delegge MH, Aisenberg J, Brill JV, Inadomi JM, Kochman ML, Piorkowski JD Jr; AGA Institute. AGA Institute review of endoscopic sedation. Gastroenterology. 2007 Aug;133(2):675-701. doi: 10.1053/j.gastro.2007.06.002. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be randomized to one of two treatment arms
Not provided
Not provided
Double Blind
| Dexmedetomidine + Midazolam 0.2 mg/kg | Drug | Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.2 mg/kg, administered 30 minutes before the induction of general anesthesia. |
|
| Child-Parent Separation Score |
Measured using the Child-Parent Separation Scale at the time of separation from parents. Scores of 1 or 2 indicate satisfactory separation; score of 3 indicates poor separation. |
| Approximately 30 minutes after premedication (at time of separation) |
| Heart Rate | Heart rate will be monitored at baseline and at the time of transfer to the operating room. Mean heart rate values will be compared between the two groups. | Baseline and immediately before anesthesia induction. |
| Blood Pressure | Mean blood pressure will be monitored at baseline and at the time of transfer to the operating room. Mean blood pressure values will be compared between the two groups. | Baseline and immediately before anesthesia induction |
| Time to Recovery (Modified Aldrete Score ≥ 9) | The time from extubation to achieving a Modified Aldrete Score of ≥9 will be recorded. | From extubation until Modified Aldrete Score ≥9 is achieved, assessed up to 1 hour in the Post-Anesthesia Care Unit (PACU) |
| Perioperative Adverse Events | Incidence of adverse effects such as nasal irritation, nausea, vomiting, paradoxical reactions, respiratory depression, etc., will be recorded and compared between groups. | From the time of drug administration until 1 hour post-discharge from the Post-Anesthesia Care Unit (PACU), or until the occurrence of a recorded adverse event, whichever comes first. |
| Souad Kafafi University Hospital, Misr University for Science and | Giza | Egypt |
|
| 10702460 | Background | Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035. |
| 14616431 | Background | Anttila M, Penttila J, Helminen A, Vuorilehto L, Scheinin H. Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003 Dec;56(6):691-3. doi: 10.1046/j.1365-2125.2003.01944.x. |
| 36301288 | Background | Dhiman T, Verma V, Kumar Verma R, Rana S, Singh J, Badhan I. Dexmedetomidine-Ketamine or Dexmedetomidine-Midazolam Nebulised Drug Combination as a Premedicant in Children: A Randomised Clinical Trial. Turk J Anaesthesiol Reanim. 2022 Oct;50(5):380-387. doi: 10.5152/TJAR.2022.21298. |
| 35626821 | Background | Gomez-Manzano FJ, Laredo-Aguilera JA, Cobo-Cuenca AI, Rabanales-Sotos J, Rodriguez-Canamero S, Martin-Espinosa N, Carmona-Torres JM. Evaluation of Intranasal Midazolam for Pediatric Sedation during the Suturing of Traumatic Lacerations: A Systematic Review. Children (Basel). 2022 Apr 29;9(5):644. doi: 10.3390/children9050644. |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided