Adenotonsillectomy
Conditions
Keywords
Pediatric anesthesia, Intranasal premedication, Dexmedetomidine intranasal, Ketamine intranasal, Midazolam intranasal, Preoperative anxiety, Respiratory complications, Laryngospasm in children
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications
Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy
DRUGIntranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications
Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy
DRUGIntranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications
Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
prospective randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria * Parent or first-degree relative acceptance * Children with age ranged from 4 to8 * Body mass index is equal to or greater than 5th and not more than 85th percentiles * ASA classifications Ⅰand Ⅱ * Both sex
Exclusion criteria
* History of difficult intubation or extubation, cardiac, respiratory, renal and muscle diseases beside passive smoking and allergy to the tested drugs * History of obstructive sleep apnea (OSA). * The presence of the upper respiratory tract infection * The need to reoperation after tonsillectomy due to hemorrhage of more than 100ml of blood during surgery * Surgery duration is longer than 1.5 hour.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the vital signs mean blood pressure | From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total) | 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. |
| Measurement of the heat rate | From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total) | 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. |
| Measurement of respiratory | From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total) | 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. |
| Scoring the incidence and severity of post-extubation laryngospasm | First 30 minutes after extubation | Incidence and severity of laryngospasm scored using a standardized 4-point scale during the first 30 minutes after extubation. |
| Assessment of the sedation level done by Ramsay sedation score | First 30 minutes post-extubation | 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. |
| Assessment of distress associated with potentially painful event using Groningen distress scale at time of canulation. | During intravenous cannulation before anesthesia induction | (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 |
| Time to achieve discharge readiness from PACU | From arrival at PACU until Modified Aldrete Score >9 is achieved, up to 2 hours postoperatively. | Monitoring for presence of sedation, nausea/vomiting, or other complications. Readiness assessed using Modified Aldrete Score. |
Countries
Egypt
Outcome results
None listed