Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing TonsillectomyPhase 4NCT06158893
Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy
A Phase 4 study testing Salbutamol, Budesonide and Saline in people with Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy, run by Assiut University.
Trial summary
Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy
- What is being tested?
- Salbutamol, Budesonide and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Oct 2025
- Phase
- Phase 4
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children scheduled for elective tonsillectomy with or without adenoidectomy, grommets cautery of inferior turbinates.
- Age more than or equal 5 years and less than or equal to 12 years.
- Both genders
- No obvious abnormalities in preoperative ECG, blood routine electrolytes and other tests.
- ASA class 1
Who cannot join
- Patients with Known hypersensitivity to any of the drugs that would be used in the study
- Patients that are immunologically compromised
- Sleep apnea syndrome or difficult airway
- Pre-existing hypoxemia is SpO2 < 90%
- History of adverse events with prior sedation or patients who had taken any sedative drugs within the last 24 hours.
- Parents refusal
Trial locations and contacts
No sites are listed yet.
About this study
Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy
Read the detailed description
Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy Adenotosillectomy is routinely performed for children with sleep disordered breathing or recurrent infectious tonsillitis. Although the safety of the pediatric anesthesia is constantly improving, a substantial proportion of children undergoing tonsillectomies experience pre operative respiratory adverse events with a prevalence up to 50% in children with at least one risk factor. Both minor adverse effects such as oxygen desaturation airway, obstruction coughing or wheezing and the major events such as laryngospasm and/ or bronchospasm occur more commonly undergoing tonsillectomy compared with other non airway surgery.
- Being tested
- Salbutamol, Budesonide, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
inhalation anaesthesia
BudesonideDrug
inhalation anaesthesia
SalineOther
saline
| Study group | Role | What they receive |
|---|---|---|
| salbutamol | Experimental | children will receive 0.15 milligram per kilogram of salbutamol diluted with normal saline to a total volume of 4 ml by inhalation 20 minutes preoperatively Receives: Drug: Salbutamol |
| budesonide | Active comparator | children will receive 0.5 milligram per kilogram of budesonide diluted with normal saline to a total volume of 4 ml by inhalation 20 minutes preoperatively Receives: Drug: Budesonide |
| normal saline | Placebo comparator | children will receive 0.4 ml of normal saline 0.9 by inhalation 20 minutes preoperatively Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of preoperative respiratory adverse events.
Will be the incidence of preoperative respiratory adverse events. events will be reported by the attending an anesthetist or PACU nurse on a dedicated data collection sheet and will be recorded against the phase of anesthesia (induction, maintenance, emergency, or recovery) during which the event occurred
Measured: 1 year
Secondary outcomes (1)
frequency of the individual PRAEs
Will be the frequency of the individual PRAEs, incidence of PRAEs during the induction and recovery periods, recovery time (the time from the end of surgery to discharge from PACU)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing TonsillectomyStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziad Shaban Redwan Helal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158893
- Sponsor's protocol ID
- children undergo Tonsillectomy
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT06158893
- Acronym / sponsor ID
- children undergo Tonsillectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 6 Dec 2023 (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.
Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy
Detailed description
Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy Adenotosillectomy is routinely performed for children with sleep disordered breathing or recurrent infectious tonsillitis. Although the safety of the pediatric anesthesia is constantly improving, a substantial proportion of children undergoing tonsillectomies experience pre operative respiratory adverse events with a prevalence up to 50% in children with at least one risk factor. Both minor adverse effects such as oxygen desaturation airway, obstruction coughing or wheezing and the major events such as laryngospasm and/ or bronchospasm occur more commonly undergoing tonsillectomy compared with other non airway surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| salbutamol | Experimental | Drug: Salbutamolchildren will receive 0.15 milligram per kilogram of salbutamol diluted with normal saline to a total volume of 4 ml by inhalation 20 minutes preoperatively |
| budesonide | Active comparator | Drug: Budesonidechildren will receive 0.5 milligram per kilogram of budesonide diluted with normal saline to a total volume of 4 ml by inhalation 20 minutes preoperatively |
| normal saline | Placebo comparator | Other: Salinechildren will receive 0.4 ml of normal saline 0.9 by inhalation 20 minutes preoperatively |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children scheduled for elective tonsillectomy with or without adenoidectomy, grommets cautery of inferior turbinates.
- Age more than or equal 5 years and less than or equal to 12 years.
- Both genders
- No obvious abnormalities in preoperative ECG, blood routine electrolytes and other tests.
- ASA class 1
Key exclusion criteria (6 listed)
- Patients with Known hypersensitivity to any of the drugs that would be used in the study
- Patients that are immunologically compromised
- Sleep apnea syndrome or difficult airway
- Pre-existing hypoxemia is SpO2 < 90%
- History of adverse events with prior sedation or patients who had taken any sedative drugs within the last 24 hours.
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 |
|---|---|---|
| Salbutamolinhalation anaesthesia | Drug | salbutamol |
| Budesonideinhalation anaesthesia | Drug | budesonide |
| Salinesaline | Other | normal saline |
Primary outcome
incidence of preoperative respiratory adverse events.
Time frame: 1 year
Will be the incidence of preoperative respiratory adverse events. events will be reported by the attending an anesthetist or PACU nurse on a dedicated data collection sheet and will be recorded against the phase of anesthesia (induction, maintenance, emergency, or recovery) during which the event occurred
1 secondary outcome
frequency of the individual PRAEs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salbutamol, Budesonide and Saline in people with Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy, run by Assiut University.
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 6 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziad SR Helal (01099483963 ext. 002, elhelal2007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of preoperative respiratory adverse events. (time frame: 1 year). 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 6 Dec 2023.