Emergency DeliriumCLONIDEXNCT07913308
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
An observational study of Emergency Delirium and Postoperative Delirium (POD), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Emergence delirium (ED) is a frequent complication in children undergoing general anesthesia, particularly following ENT procedures such as adenotonsillectomy. Alpha-2 adrenergic agonists, such as clonidine and dexmedetomidine, are commonly used in pediatric anesthesia for their sedative, analgesic, and ED-reducing… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Emergency Delirium, Postoperative Delirium (POD), Adenotonsillectomy
- What is being tested?
- Intravenous dexmedetomidine, Intravenous clonidine and Standard Anesthetic Care Without Alpha-2 Agonist
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2026to 31 May 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of pediatric patients aged 2 to 12 years (ASA I-II) scheduled for elective ambulatory (adeno)tonsillectomy with or without placement of myringotomy tubes under general anesthesia at UZ Brussel. Participants are selected from the daily operating room list in the day-surgery unit.
Who may be able to join
- Children aged 2 to 12 years old.
- Scheduled for elective (adeno)tonsillectomy or tonsillectomy (with or without concurrent myringotomy/tympanostomy tube insertion).
- American Society of Anesthesiologists (ASA) physical status I or II.
- Surgery performed in an ambulatory / day-surgery setting under general anesthesia.
- Written informed consent provided by parents or legal guardians.
Who cannot join
- Known hypersensitivity or allergy to clonidine, dexmedetomidine, or other alpha-2 adrenergic agonists.
- Pre-existing severe cardiac conduction abnormalities, severe bradycardia, or hemodynamic instability.
- Severe neurodevelopmental impairment, severe cognitive impairment, or active central nervous system disorders that preclude reliable assessment using the PAED scale.
- Emergency tonsillectomy or active tonsillar hemorrhage.
- Patients requiring planned postoperative intensive care unit (PICU) admission or extended inpatient monitoring.
- Patient or parent/guardian refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Liza De Dobbeleer, Study Nurse contact
Belgium1 site
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Hélène De Cuyper, MD, +3224749765, helene.decuyper@uzbrussel.be
About this study
Official title: Comparison of Intravenously Administered Dexmedetomidine Versus Clonidine Versus No Alpha-2 Agonist on Emergence Delirium, PACU Length of Stay, and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: A Prospective Observational Study
Emergence delirium (ED) is a frequent complication in children undergoing general anesthesia, particularly following ENT procedures such as adenotonsillectomy. Alpha-2 adrenergic agonists, such as clonidine and dexmedetomidine, are commonly used in pediatric anesthesia for their sedative, analgesic, and ED-reducing properties.The purpose of this prospective observational study (CLONIDEX) is to evaluate and compare the occurrence of emergence delirium, Post-Anesthesia Care Unit (PACU) length of stay, and overall time to hospital discharge in pediatric patients undergoing (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intravenous dexmedetomidine, intravenous clonidine, or no alpha-2 agonist as part of their standard anesthetic care.
Read the detailed description
Background:
Emergence delirium (ED) in pediatric patients leads to increased post-anesthesia care unit (PACU) complications, distress for parents and staff, and potential physical injury. While both clonidine and dexmedetomidine are widely utilized alpha-2 agonists in pediatric practice, real-world prospective comparative data regarding their relative efficacy on ED incidence and recovery timelines remain limited.
Study Design and Methodology This is a single-center, prospective observational cohort study conducted at UZ Brussel. Because this is an observational study evaluating standard-of-care practices, the administration and choice of alpha-2-agonist (IV dexmedetomidine, IV clonidine, or no alpha-2-agonist) are left entirely to the discretion of the attending pediatric anesthesiologist.
Data Collection and Outcomes:
Pediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes will be observed. Key demographic data, anesthetic techniques, and intraoperative co-analgesics will be recorded. Upon arrival in the PACU, emergence delirium will be systematically assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale at set time intervals (arrival, 15, 30, 45, and 60 minutes). Secondary endpoints include PACU length of stay (measured against standardized discharge readiness criteria), total time to hospital discharge, requirement for rescue medication, and incidence of perioperative adverse events (such as postoperative nausea and vomiting, desaturation, or laryngospasm).
- Conditions
- Emergency Delirium, Postoperative Delirium (POD), Adenotonsillectomy, Tonsillectomy, Postoperative Pain, Pediatric Anesthesia Complications
- Being tested
- Intravenous dexmedetomidine, Intravenous clonidine, Standard Anesthetic Care Without Alpha-2 Agonist
- Keywords
- Dexmedetomidine, Clonidine, Alpha-2 adrenergic agonist, Emergency delirium, Pediatric Anesthesia, Adenotonsillectomy, Tonsillectomy, PAED scale, PACU length of stay, Hospital discharge time, Postoperative Recovery
- Medical subject headings
- Emergence Delirium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous dexmedetomidineDrug
Standard of care intraoperative intravenous administration of dexmedetomidine. Dose, timing, and administration are determined solely by the attending anesthesiologist.
Intravenous clonidineDrug
Standard of care intraoperative intravenous administration of clonidine. Dose, timing, and administration are determined solely by the attending anesthesiologist.
Standard Anesthetic Care Without Alpha-2 AgonistOther
Standard anesthetic care during pediatric (adeno)tonsillectomy without administration of intraoperative alpha-2 adrenergic agonists.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Pediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intraoperative intravenous dexmedetomidine as part of standard anesthetic care, at the discretion of the attending anesthesiologist. Receives: Drug: Intravenous dexmedetomidine | |
| Clonidine Group | Pediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intraoperative intravenous clonidine as part of standard anesthetic care, at the discretion of the attending anesthesiologist. Receives: Drug: Intravenous clonidine | |
| Control Group (No Alpha-2 Agonist) | Pediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes who do not receive any intraoperative alpha-2 adrenergic agonist (dexmedetomidine or clonidine) as part of standard anesthetic care. Receives: Other: Standard Anesthetic Care Without Alpha-2 Agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Emergence Delirium (ED)
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale consists of 5 items, with total scores ranging from 0 to 20, where higher scores indicate greater severity of delirium. A PAED score >= 10 (or >= 12) is defined as the presence of emergence delirium.
Measured: Assessed at PACU arrival (T0), and at 15 (T15), 30 (T30), 45 (T45), and 60 (T60) minutes post-operatively until PACU discharge.
Secondary outcomes (4)
Post-Anesthesia Care Unit (PACU) Length of Stay
Time duration (in minutes) from arrival at the PACU until meeting formal criteria for discharge readiness (e.g., modified Aldrete or PADSS score).
Measured: From arrival at PACU until discharge readiness, assessed up to 2 hours post-operatively.
Total Time to Hospital Discharge
Time duration (in hours) from the end of anesthesia/surgery until actual discharge from the day-surgery clinic.
Measured: From end of surgery until hospital discharge on Day 1 (up to 24 hours).
Incidence of Rescue Medication Administration
Proportion of patients requiring rescue medication in the PACU for severe emergence delirium or acute postoperative pain (e.g., propofol, opioids, or additional alpha-2 agonists).
Measured: During the PACU stay, up to 2 hours post-operatively.
Incidence of Perioperative Adverse Events
Occurrence of airway or recovery complications including laryngospasm, oxygen desaturation (<92%), severe postoperative nausea and vomiting (PONV), or excessive sedation.
Measured: From anesthesia induction until discharge from the day-surgery clinic (up to 24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency DeliriumStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hélène De Cuyper, Universitair Ziekenhuis Brussel
- Investigators
- Hélène De Cuyper, MD, Principal investigator, Department of Anesthesiology & Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913308
- Sponsor's protocol ID
- CLONIDEX
- Acronym
- CLONIDEX
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Privacy \& GDPR Compliance: The study involves a vulnerable pediatric population. Full individual participant data sets, even if pseudonymized, carry a risk of re-identification when combined with detailed clinical and surgical variables, which violates strict European General Data Protection Regulation (GDPR) standards and institutional patient privacy policies. Absence of Informed Consent for Broad Public Data Sharing: The informed consent process and ethics committee approval approved for this study specifically cover data collection and analysis by the designated investigation team at UZ Brussel. Participants' legal guardians did not consent to open-access public repository sharing or secondary use of their children's raw individual data by external third parties. Institutional \& Regulatory Restrictions: In accordance with hospital policy and national regulatory frameworks governing single-center observational clinical research, raw patient-level data remain restricted.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenously Administered Dexmedetomidine Versus Clonidine Versus No Alpha-2 Agonist on Emergence Delirium, PACU Length of Stay, and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07913308
- Acronym / sponsor ID
- CLONIDEX / CLONIDEX
- Conditions
- Emergency Delirium, Postoperative Delirium (POD), Adenotonsillectomy, Tonsillectomy, Postoperative Pain, Pediatric Anesthesia Complications
- Keywords
- Dexmedetomidine, Clonidine, Alpha-2 adrenergic agonist, Emergency delirium, Pediatric Anesthesia, Adenotonsillectomy, Tonsillectomy, PAED scale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
Emergence delirium (ED) is a frequent complication in children undergoing general anesthesia, particularly following ENT procedures such as adenotonsillectomy. Alpha-2 adrenergic agonists, such as clonidine and dexmedetomidine, are commonly used in pediatric anesthesia for their sedative, analgesic, and ED-reducing properties.The purpose of this prospective observational study (CLONIDEX) is to evaluate and compare the occurrence of emergence delirium, Post-Anesthesia Care Unit (PACU) length of stay, and overall time to hospital discharge in pediatric patients undergoing (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intravenous dexmedetomidine, intravenous clonidine, or no alpha-2 agonist as part of their standard anesthetic care.
Detailed description
Background:
Emergence delirium (ED) in pediatric patients leads to increased post-anesthesia care unit (PACU) complications, distress for parents and staff, and potential physical injury. While both clonidine and dexmedetomidine are widely utilized alpha-2 agonists in pediatric practice, real-world prospective comparative data regarding their relative efficacy on ED incidence and recovery timelines remain limited.
Study Design and Methodology This is a single-center, prospective observational cohort study conducted at UZ Brussel. Because this is an observational study evaluating standard-of-care practices, the administration and choice of alpha-2-agonist (IV dexmedetomidine, IV clonidine, or no alpha-2-agonist) are left entirely to the discretion of the attending pediatric anesthesiologist.
Data Collection and Outcomes:
Pediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes will be observed. Key demographic data, anesthetic techniques, and intraoperative co-analgesics will be recorded. Upon arrival in the PACU, emergence delirium will be systematically assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale at set time intervals (arrival, 15, 30, 45, and 60 minutes). Secondary endpoints include PACU length of stay (measured against standardized discharge readiness criteria), total time to hospital discharge, requirement for rescue medication, and incidence of perioperative adverse events (such as postoperative nausea and vomiting, desaturation, or laryngospasm).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | – | Drug: Intravenous dexmedetomidinePediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intraoperative intravenous dexmedetomidine as part of standard anesthetic care, at the discretion of the attending anesthesiologist. |
| Clonidine Group | – | Drug: Intravenous clonidinePediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intraoperative intravenous clonidine as part of standard anesthetic care, at the discretion of the attending anesthesiologist. |
| Control Group (No Alpha-2 Agonist) | – | Other: Standard Anesthetic Care Without Alpha-2 AgonistPediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes who do not receive any intraoperative alpha-2 adrenergic agonist (dexmedetomidine or clonidine) as part of standard anesthetic care. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of pediatric patients aged 2 to 12 years (ASA I-II) scheduled for elective ambulatory (adeno)tonsillectomy with or without placement of myringotomy tubes under general anesthesia at UZ Brussel. Participants are selected from the daily operating room list in the day-surgery unit.
Key inclusion criteria (5 listed)
- Children aged 2 to 12 years old.
- Scheduled for elective (adeno)tonsillectomy or tonsillectomy (with or without concurrent myringotomy/tympanostomy tube insertion).
- American Society of Anesthesiologists (ASA) physical status I or II.
- Surgery performed in an ambulatory / day-surgery setting under general anesthesia.
- Written informed consent provided by parents or legal guardians.
Key exclusion criteria (6 listed)
- Known hypersensitivity or allergy to clonidine, dexmedetomidine, or other alpha-2 adrenergic agonists.
- Pre-existing severe cardiac conduction abnormalities, severe bradycardia, or hemodynamic instability.
- Severe neurodevelopmental impairment, severe cognitive impairment, or active central nervous system disorders that preclude reliable assessment using the PAED scale.
- Emergency tonsillectomy or active tonsillar hemorrhage.
- Patients requiring planned postoperative intensive care unit (PICU) admission or extended inpatient monitoring.
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 |
|---|---|---|
| Intravenous dexmedetomidineStandard of care intraoperative intravenous administration of dexmedetomidine. Dose, timing, and administration are determined solely by the attending anesthesiologist. | Drug | Dexmedetomidine Group |
| Intravenous clonidineStandard of care intraoperative intravenous administration of clonidine. Dose, timing, and administration are determined solely by the attending anesthesiologist. | Drug | Clonidine Group |
| Standard Anesthetic Care Without Alpha-2 AgonistStandard anesthetic care during pediatric (adeno)tonsillectomy without administration of intraoperative alpha-2 adrenergic agonists. | Other | Control Group (No Alpha-2 Agonist) |
Primary outcome
Incidence and Severity of Emergence Delirium (ED)
Time frame: Assessed at PACU arrival (T0), and at 15 (T15), 30 (T30), 45 (T45), and 60 (T60) minutes post-operatively until PACU discharge.
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale consists of 5 items, with total scores ranging from 0 to 20, where higher scores indicate greater severity of delirium. A PAED score >= 10 (or >= 12) is defined as the presence of emergence delirium.
4 secondary outcomes
Post-Anesthesia Care Unit (PACU) Length of Stay
Time frame: From arrival at PACU until discharge readiness, assessed up to 2 hours post-operatively.
Total Time to Hospital Discharge
Time frame: From end of surgery until hospital discharge on Day 1 (up to 24 hours).
Incidence of Rescue Medication Administration
Time frame: During the PACU stay, up to 2 hours post-operatively.
Incidence of Perioperative Adverse Events
Time frame: From anesthesia induction until discharge from the day-surgery clinic (up to 24 hours).
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Patient Privacy \& GDPR Compliance: The study involves a vulnerable pediatric population. Full individual participant data sets, even if pseudonymized, carry a risk of re-identification when combined with detailed clinical and surgical variables, which violates strict European General Data Protection Regulation (GDPR) standards and institutional patient privacy policies. Absence of Informed Consent for Broad Public Data Sharing: The informed consent process and ethics committee approval approved for this study specifically cover data collection and analysis by the designated investigation team at UZ Brussel. Participants' legal guardians did not consent to open-access public repository sharing or secondary use of their children's raw individual data by external third parties. Institutional \& Regulatory Restrictions: In accordance with hospital policy and national regulatory frameworks governing single-center observational clinical research, raw patient-level data remain restricted.
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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.
Liza De Dobbeleer, Study Nurse contact
Hélène De Cuyper, MD principal investigator
Department of Anesthesiology & Perioperative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Delirium and Postoperative Delirium (POD), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 Belgium. 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 Hélène De Cuyper, MD (+3224749765, helene.decuyper@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Emergence Delirium (ED) (time frame: Assessed at PACU arrival (T0), and at 15 (T15), 30 (T30), 45 (T45), and 60 (T60) minutes post-operatively until PACU discharge.). 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 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.