AdenotonsillectomySZMBNCT07013526
Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy
A study testing Ropivacaine in people with Adenotonsillectomy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The goal of this clinic trial is to evaluate the impact of dexmedetomidine as an adjunct pain pain medication on opioid-free recovery in children undergoing adenotonsillectomy with Suprazygomatic maxillary nerve block (SZMB). Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Adenotonsillectomy
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scheduled for elective partial adenotonsillectomy,
- STUBR score ≥ 3, indicating significant sleep-disordered breathing
- Patients whose parents are fluent in French of English will be enrolled
Who cannot join
- Scheduled to undergo total extracapsular adenotonsillectomy or adenoidectomy-only procedures
- Patient requires prolonged intubation postoperatively
- the anesthesiologist does not adhere to the standardized anesthesia protocol
- Patients with neurological or cardiac congenital deficits, with cardiac arrhythmias (non-sinus rhythm), implanted pacemakers, on chronic therapy with drugs that have known effects on sympathetic and parasympathetic activity (antimuscarinics, beta-2 adrenergic agonists, alpha-1 adrenergic antagonists or antiarrhythmic agents, tricyclic antidepressants)
- ASA physical status III or higher
- Parent/legal guardians refuses to participate
- Patients scheduled for surgery without an appointment at the Montreal Children's Hospital (MCH) Preoperative Clinic will not be enrolled in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Gianluca Bertolizio, MD, FRCPC, 5144124400, gianluca.bertolizio@mcgill.ca
About this study
Official title: Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy: a Randomized Controlled Trial Study
The goal of this clinic trial is to evaluate the impact of dexmedetomidine as an adjunct pain pain medication on opioid-free recovery in children undergoing adenotonsillectomy with Suprazygomatic maxillary nerve block (SZMB). The main questions it aims to answer are:
- Does SZMB with the local anesthetic ropivacaine and the adjuvant dexmedetomidine result in less pain
- Is dexmedetomidine associated with an improved quality of recovery at home Researchers will compare pain in participants given an SZMB with ropivacaine and an adjuvant dexmedetomidine, participants given SZMB with ropivacaine only, and a SZMB with ropivacaine and dexmedetomidine given intravenously.
Read more
Participants will:
- Be given the SZMB during the surgery.
- Be evaluated after surgery to measure their opioid consumption, pain severity, level of agitation, and level of delirium
- Complete a daily questionnaire for 7 days after surgery on the patients pain and recovery
- Conditions
- Adenotonsillectomy
- Being tested
- Ropivacaine
- Keywords
- pain, opioid-free recovery, Suprazygomatic maxillary nerve block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineProcedure or surgery
Administration of ropivacaine in a Suprazygomatic maxillary nerve block
| Study group | Role | What they receive |
|---|---|---|
| Group R | Other | Group R will receive an SZMB of 0.15 ml/kg of local anesthetic ropivacaine 0.2% (max 5 ml). After the block, 0.1 ml/kg of normal saline will be administered intravenously. No dexmedetomidine will be given. Receives: Procedure: Ropivacaine |
| Group RD | Experimental | 2. Group RD will receive an SZMB of 0.1 ml/kg of a solution of local anesthetic ropivacaine 0.2% and dexmedetomidine 1 mcg/ml (max 5 ml). After the block, 0.1 ml/kg of normal saline will be administered intravenously. No dexmedetomidine i.v. will be given. Receives: Procedure: Ropivacaine |
| Group D | Other | Group D will receive an SMB of 0.1 ml/kg of local anesthetic ropivacaine 0.2% (max 5 ml). After the block a bolus of intravenous dexmedetomidine 0.25 mcg/kg i.v. will be given. Receives: Procedure: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid-free recovery
Incidence of patients not requiring opioids in the PACU after surgery
Measured: 2 hours
Secondary outcomes (4)
Number of patients with postoperative Pain
Patients were classified as having pain if they had a Face, Activity, Cry, Consolability (FLACC) score that was greater than or equal to 3.
Measured: 2 hours
Number of Patients with Emergence Delirium
Patients were classified as having emergence delirium if they had a score on the emergence delirium scale that was greater than or equal to 10 in the Post-anesthesia care unit.
Measured: 2 hours
Pain through follow-up
Difference in pain between the groups, assessed with the Parents' Postoperative Pain Measure
Measured: 7 days
Quality of Recovery through follow-up
Differences in the Quality of recovery between the groups, as measured by the Post-Hospitalization Behavior Questionnaire for Ambulatory Surgery.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Bertolizio, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013526
- Sponsor's protocol ID
- 2026-11731
- Acronym
- SZMB
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy: a Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT07013526
- Acronym / sponsor ID
- SZMB / 2026-11731
- Conditions
- Adenotonsillectomy
- Keywords
- pain, opioid-free recovery, Suprazygomatic maxillary nerve block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Jun 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.
The goal of this clinic trial is to evaluate the impact of dexmedetomidine as an adjunct pain pain medication on opioid-free recovery in children undergoing adenotonsillectomy with Suprazygomatic maxillary nerve block (SZMB). The main questions it aims to answer are:
- Does SZMB with the local anesthetic ropivacaine and the adjuvant dexmedetomidine result in less pain
- Is dexmedetomidine associated with an improved quality of recovery at home Researchers will compare pain in participants given an SZMB with ropivacaine and an adjuvant dexmedetomidine, participants given SZMB with ropivacaine only, and a SZMB with ropivacaine and dexmedetomidine given intravenously.
Participants will:
- Be given the SZMB during the surgery.
- Be evaluated after surgery to measure their opioid consumption, pain severity, level of agitation, and level of delirium
- Complete a daily questionnaire for 7 days after surgery on the patients pain and recovery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group R | Other | Procedure: RopivacaineGroup R will receive an SZMB of 0.15 ml/kg of local anesthetic ropivacaine 0.2% (max 5 ml). After the block, 0.1 ml/kg of normal saline will be administered intravenously. No dexmedetomidine will be given. |
| Group RD | Experimental | Procedure: Ropivacaine2. Group RD will receive an SZMB of 0.1 ml/kg of a solution of local anesthetic ropivacaine 0.2% and dexmedetomidine 1 mcg/ml (max 5 ml). After the block, 0.1 ml/kg of normal saline will be administered intravenously. No dexmedetomidine i.v. will be given. |
| Group D | Other | Procedure: RopivacaineGroup D will receive an SMB of 0.1 ml/kg of local anesthetic ropivacaine 0.2% (max 5 ml). After the block a bolus of intravenous dexmedetomidine 0.25 mcg/kg i.v. will be given. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Scheduled for elective partial adenotonsillectomy,
- STUBR score ≥ 3, indicating significant sleep-disordered breathing
- Patients whose parents are fluent in French of English will be enrolled
Key exclusion criteria (7 listed)
- Scheduled to undergo total extracapsular adenotonsillectomy or adenoidectomy-only procedures
- Patient requires prolonged intubation postoperatively
- the anesthesiologist does not adhere to the standardized anesthesia protocol
- Patients with neurological or cardiac congenital deficits, with cardiac arrhythmias (non-sinus rhythm), implanted pacemakers, on chronic therapy with drugs that have known effects on sympathetic and parasympathetic activity (antimuscarinics, beta-2 adrenergic agonists, alpha-1 adrenergic antagonists or antiarrhythmic agents, tricyclic antidepressants)
- ASA physical status III or higher
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 |
|---|---|---|
| RopivacaineAdministration of ropivacaine in a Suprazygomatic maxillary nerve block | Procedure or surgery | Group D, Group R, Group RD |
Primary outcome
Opioid-free recovery
Time frame: 2 hours
Incidence of patients not requiring opioids in the PACU after surgery
4 secondary outcomes
Number of patients with postoperative Pain
Time frame: 2 hours
Number of Patients with Emergence Delirium
Time frame: 2 hours
Pain through follow-up
Time frame: 7 days
Quality of Recovery through follow-up
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Adenotonsillectomy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 10 Jun 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 Canada. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Bertolizio, MD, FRCPC (514586-2674, gianluca.bertolizo@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid-free recovery (time frame: 2 hours). 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 10 Jun 2025.