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| ID | Type | Description | Link |
|---|---|---|---|
| ZU-IRB#10231/11-1-2023 | Other Identifier | Zagazig University Institutional Review Board |
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This study is being done to find out which of three medications-dexmedetomidine, ketamine, or midazolam-is best at reducing anxiety and breathing problems in children having surgery to remove their tonsils and adenoids. These medicines will be given as nose drops before anesthesia. Anxiety before surgery can cause stress and lead to problems like trouble breathing during or after surgery. The study will include 148 children aged 4 to 8 years. Each child will get one of the three medicines or a placebo (saline). Researchers will observe the children for signs of anxiety before surgery and for breathing problems, such as laryngospasm, after they wake up. The goal is to find the safest and most effective medicine to help children feel calmer and breathe safely during surgery.
Preoperative anxiety and respiratory complications are common in children undergoing adenotonsillectomy. Anxiety may result in behavioral changes and is associated with more difficult inductions and poorer recovery. Respiratory complications such as laryngospasm and airway obstruction are particularly dangerous in children, and minimizing these risks is a key goal of pediatric anesthesia.
Premedication with sedative drugs may help reduce anxiety and promote a smoother induction of anesthesia. The intranasal route of drug delivery is non-invasive and well tolerated in children, offering high bioavailability and avoiding the stress of IV insertion before surgery. Three commonly used intranasal medications-dexmedetomidine, ketamine, and midazolam-each have different pharmacological profiles and potential benefits.Dexmedetomidine is a selective alpha-2 adrenergic agonist that provides sedation and anxiolysis without causing respiratory depression. Ketamine is a dissociative anesthetic that reduces pain sensitivity and maintains respiratory drive. Midazolam is a benzodiazepine that provides rapid sedation and amnesia.
This randomized controlled trial will include 148 children aged 4 to 8 years undergoing adenotonsillectomy. Children will be randomly assigned to one of four groups: intranasal dexmedetomidine, ketamine, midazolam, or saline (placebo). The study is double-blinded, and the medications will be administered 30 minutes before anesthesia induction.
The primary goal is to assess and compare the incidence and severity of post-extubation laryngospasm within 30 minutes of extubation. Secondary objectives include assessing sedation level, preoperative anxiety, distress during IV cannulation, vital signs, and discharge readiness using standardized scoring systems such as the Ramsay Sedation Score, Groningen Distress Scale, and the Modified Aldrete Score.
The results of this study aim to determine the most effective and safest intranasal sedative premedication for pediatric patients, with the goal of improving surgical experiences, reducing complications, and enhancing recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | Patients will receive 1 mL of 0.9% saline intranasally 30 minutes before induction of anesthesia. |
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| Dexmedetomidine Group | Experimental | Patients will receive 2.0 μg/kg of intranasal dexmedetomidine, diluted in 0.9% saline to a total volume of 1 mL, 30 minutes before anesthesia induction. |
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| Ketamine Group | Experimental | Patients will receive 2 mg/kg of intranasal ketamine (50 mg/mL), diluted with 0.9% saline to a total volume of 1 mL, administered 30 minutes prior to anesthesia induction. |
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| Midazolam Group | Experimental | Patients will receive 0.1 mg/kg of intranasal midazolam, diluted in 0.9% saline to a final volume of 1 mL, administered 30 minutes before anesthesia induction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications | Drug | Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the vital signs mean blood pressure | Mean arterial pressure (MAP) measured at seven time points: baseline (before intranasal drug), 10 minutes after drug administration, at induction, 10 and 30 minutes intraoperatively, and 10 and 30 minutes postoperatively. | From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total) |
| Measurement of the heat rate | Heart rate measured at seven time points: baseline, 10 minutes after drug administration, at induction, 10 and 30 minutes intraoperatively, and 10 and 30 minutes postoperatively. | From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total) |
| Measurement of respiratory | Respiratory rate measured at seven time points: baseline, 10 minutes after drug administration, at induction, 10 and 30 minutes intraoperatively, and 10 and 30 minutes postoperatively. | From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total) |
| Scoring the incidence and severity of post-extubation laryngospasm | Incidence and severity of laryngospasm scored using a standardized 4-point scale during the first 30 minutes after extubation. | First 30 minutes after extubation |
| Assessment of the sedation level done by Ramsay sedation score | Assessment of the sedation level done by Ramsay sedation score will be recoded at different time intervals: preoperative baseline before administration of intranasal medication, then 10 min, just before induction and 10 min, 20 min postoperative. "Ramsay Sedation Score" is described in 1974 it divides the pts level of sedation into 6 Categories ranging from severe agitation to deep coma. | First 30 minutes post-extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amira Saeed Kenawy, MD | Faculty of Medicine - Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine - Zagazig University | Zagazig | Egypt |
Individual participant data (IPD) will not be shared due to ethical considerations, institutional policies, and the involvement of pediatric participants. The study does not have a formal data-sharing mechanism, and the data contain potentially sensitive health information related to children.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2023 | Jul 8, 2025 |
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prospective randomized controlled clinical trial
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The study is double-blinded. The patients and anesthesia assistant (the person evaluating the effect of the tested drug) will not be informed about tested drug. Only the anesthesiologist (the person prescribing the tested drug) will be aware.
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| Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications | Drug | Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy |
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| Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications | Drug | Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy |
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| Assessment of the sedation level done by Ramsay sedation score | Sedation level assessed using Ramsay Sedation Score at five time points: preoperative baseline (before drug administration), 10 minutes after drug, immediately before induction, and at 10 and 20 minutes postoperatively. The Ramsay Sedation Score is a 6-point scale ranging from anxiety/agitation to deep unresponsiveness. | From baseline to 20 minutes after surgery (approximately 1 hour total) |
| Assessment of distress associated with potentially painful event using Groningen distress scale at time of canulation. | (GDS) was developed to grade distress associated with a potentially painful event. It can be used to monitor a phobic patient's experience towards a triggering stimulus. The original scale was developed at the University of Groningen in The Netherland | During intravenous cannulation before anesthesia induction |
| Time to achieve discharge readiness from PACU | Monitoring for presence of sedation, nausea/vomiting, or other complications. Readiness assessed using Modified Aldrete Score. | From arrival at PACU until Modified Aldrete Score >9 is achieved, up to 2 hours postoperatively. |
| Prot_000.pdf |