Tonsillar HypertrophyNCT04057469
Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy
A study testing Tulobuterol Hydrochloride in people with Tonsillar Hypertrophy, run by Seoul National University Hospital at 4 sites in South Korea.
Trial summary
Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Tonsillar Hypertrophy
- What is being tested?
- Tulobuterol Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 20 Dec 2019to 30 Sep 2021
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients undergoing tonsillectomy
Who cannot join
- recent upper respiratory infection (2weeks)
- Allergy to tulobuterol patch
- Patients receiving catecholamine (epinephrine, isoproterenol)
- hyperthyroidism
- hypertension
- cardiac disease
Show all 9Show fewer
- Diabetes melitus
- atopic dermatitis
- Asthma
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Hyun-Joo Kim
Seoul, 03721
Jin-Kyung Kim
Seoul, 06351
Chung-Ang University Hospital
Seoul, 06973
About this study
Official title: Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
- Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event.
- We tried to determine whether tulobuterol patch (transdermal bronchodilator) premedication decreases the risk of perioperative respiratory adverse events in children undergoing anesthesia for tonsillectomy.
- Conditions
- Tonsillar Hypertrophy
- Being tested
- Tulobuterol Hydrochloride, Placebo transdermal patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tulobuterol HydrochlorideDrug
The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.
Placebo transdermal patchDrug
The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| Tulobuterol patch | Experimental | Not described Receives: Drug: Tulobuterol Hydrochloride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative respiratory complication
laryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor
Measured: from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start20 Dec 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tonsillar HypertrophyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Chung-Ang University Hospital, Severance Hospital
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057469
- Sponsor's protocol ID
- 1905-178-103
- Status last verified
- Dec 2021
- First submitted
- 12 Aug 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim EH, Lee SH, Kim JK, Park YH, Kang P, Park JB, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS. Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: A Randomized Controlled Trial. Anesth Analg. 2023 Jun 1;136(6):1067-1074. doi: 10.1213/ANE.0000000000006355. Epub 2023 May 19.
PubMed 36727868
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
- ClinicalTrials.gov ID
- NCT04057469
- Acronym / sponsor ID
- 1905-178-103
- Conditions
- Tonsillar Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Chung-Ang University Hospital, Severance Hospital
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 Aug 2019 (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.
- Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event.
- We tried to determine whether tulobuterol patch (transdermal bronchodilator) premedication decreases the risk of perioperative respiratory adverse events in children undergoing anesthesia for tonsillectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tulobuterol patch | Experimental | Drug: Tulobuterol Hydrochloride |
| Placebo | Placebo comparator | Drug: Placebo transdermal patch |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients undergoing tonsillectomy
Key exclusion criteria (9 listed)
- recent upper respiratory infection (2weeks)
- Allergy to tulobuterol patch
- Patients receiving catecholamine (epinephrine, isoproterenol)
- hyperthyroidism
- hypertension
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 |
|---|---|---|
| Tulobuterol HydrochlorideThe appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours. | Drug | Tulobuterol patch |
| Placebo transdermal patchThe appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours. | Drug | Placebo |
Primary outcome
perioperative respiratory complication
Time frame: from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours
laryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor
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 14 Jan 2022.
- Derived from this study: PubMed 36727868Kim EH, Lee SH, Kim JK, Park YH, Kang P, Park JB, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS. Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: A Randomized Controlled Trial. Anesth Analg. 2023 Jun 1;136(6):1067-1074. doi: 10.1213/ANE.0000000000006355. Epub 2023 May 19.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tulobuterol Hydrochloride in people with Tonsillar Hypertrophy, run by Seoul National University Hospital at 4 sites in South Korea.
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 1 inclusion and 9 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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?
perioperative respiratory complication (time frame: from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04057469, which also lists 1 linked publication.
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 14 Jan 2022.