AdenotonsillectomyINPERMNCT07072117
Intranasal Dexmedetomidine, Ketamine or Midazolam for Anxiety and Respiratory Complications in Children
A study testing Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications, Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications and Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications in people with Adenotonsillectomy, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Adenotonsillectomy
- What is being tested?
- Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications, Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications and Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Intranasal Dexmedetomidine, Ketamine or Midazolam for Reducing Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy
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.
Read the 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.
- Conditions
- Adenotonsillectomy
- Being tested
- Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications, Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications, Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications
- Keywords
- Pediatric anesthesia, Intranasal premedication, Dexmedetomidine intranasal, Ketamine intranasal, Midazolam intranasal, Preoperative anxiety, Respiratory complications, Laryngospasm in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory ComplicationsDrug
Also called Intranasal Dexmedetomidine
Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy
Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory ComplicationsDrug
Also called Intranasal Ketamine
Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy
Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory ComplicationsDrug
Also called Intranasal Midazolam
Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Patients will receive 1 mL of 0.9% saline intranasally 30 minutes before induction of anesthesia. Receives: Drug: Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications; Drug: Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications; Drug: Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications |
| 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. Receives: Drug: Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications |
| 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. Receives: Drug: Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications |
| 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. Receives: Drug: Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First 30 minutes post-extubation
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.
Measured: 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
Measured: 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.
Measured: From arrival at PACU until Modified Aldrete Score >9 is achieved, up to 2 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start20 Feb 2023
- Primary completion20 Aug 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenotonsillectomyStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amira Saieed Elsayed Mousa, Zagazig University
- Investigators
- Amira Saeed Kenawy, MD, Principal investigator, Faculty of Medicine - Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072117
- Sponsor's protocol ID
- zagu2025-INSI
- Other IDs
- ZU-IRB#10231/11-1-2023
- Acronym
- INPERM
- Status last verified
- Jul 2025
- First submitted
- 22 May 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intranasal Dexmedetomidine, Ketamine or Midazolam for Reducing Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT07072117
- Acronym / sponsor ID
- INPERM / zagu2025-INSI
- Conditions
- Adenotonsillectomy
- Keywords
- Pediatric anesthesia, Intranasal premedication, Dexmedetomidine intranasal, Ketamine intranasal, Midazolam intranasal, Preoperative anxiety, Respiratory complications, Laryngospasm in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications, Drug: Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications, Drug: Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory ComplicationsPatients will receive 1 mL of 0.9% saline intranasally 30 minutes before induction of anesthesia. |
| Dexmedetomidine Group | Experimental | Drug: Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory ComplicationsPatients 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. |
| Ketamine Group | Experimental | Drug: Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory ComplicationsPatients 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. |
| Midazolam Group | Experimental | Drug: Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory ComplicationsPatients 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. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory ComplicationsAlso: Intranasal DexmedetomidineIntranasal Dexmedetomidine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy | Drug | Dexmedetomidine Group, control group |
| Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory ComplicationsAlso: Intranasal KetamineIntranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy | Drug | Ketamine Group, control group |
| Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory ComplicationsAlso: Intranasal MidazolamIntranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications in Children Undergoing Adenotonsillectomy | Drug | Midazolam Group, control group |
Primary outcome
Measurement of the vital signs mean blood pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 the sedation level done by Ramsay sedation score
Time frame: From baseline to 20 minutes after surgery (approximately 1 hour total)
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.
Assessment of distress associated with potentially painful event using Groningen distress scale at time of canulation.
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira Saeed Kenawy, MD principal investigator
Faculty of Medicine - Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal Dexmedetomidine as a Premedication for Prevention of Anxiety & Respiratory Complications, Intranasal Ketamine as a Premedication for Prevention of Anxiety and Respiratory Complications and Intranasal Midazolam as a Premedication for Prevention of Anxiety and Respiratory Complications in people with Adenotonsillectomy, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the vital signs mean blood pressure (time frame: From 30 minutes pre-induction to 30 minutes post-extubation (approximately 1 hour total)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.