Liquid OxycodonePhase 4NCT03054831
The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric
A Phase 4 study testing liquid oxycodone in people with Liquid Oxycodone, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used in adults and children to relieve post-operative pain. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Liquid Oxycodone
- What is being tested?
- liquid oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to Dec 2027
- Phase
- Phase 4
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients are scheduled for the following in-patient surgical procedures:
- hypospadias repair
- ureteral reimplantation
- pyeloplasty (Genitourinary Surgery Service) and age between 2-8 years, and opioid naive, and not meet exclusion criteria
Who cannot join
- currently taking cytochrome P450(CYP) 3A4 or 2D6 inhibitors/inducers
- known history of allergy to oxycodone
- known gastrointestinal, hepatic, or renal dysfunction
- known sleep apnea or impaired respiratory reserve
- speak a language other than English
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children Hospital
Boston, Massachusetts, 02115
About this study
Official title: The Effect of General Anesthesia on Pharmacokinetics and Pharmacogenomics of Liquid Oxycodone in Pediatric Surgical Patients
Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it does in the body) and pharmacodynamics (how it works) have not been well established in children. Some children, because of their specific genetic make-up, may metabolize the drug more quickly and therefore may be at risk for more side effects in the commonly prescribed dose. The investigators would like to find out more about how general anesthesia (GA) effects how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, the investigators would like to give oxycodone to surgical patients (group one will receive oxycodone at the beginning of GA and group two will receive oxycodone at the end of GA) at Boston Children's Hospital then measure its metabolic activity and also perform a specific genetic analysis.
Read the detailed description
This research will involve two treatment groups: (children 2-5 years old) and (children 6-8 years old). The first group will include 20 children 2-5 years old. In this group the children will be randomized to either receive 0.1mg/kg of liquid oxycodone via an orogastric (OG) tube after induction but before the procedure at the beginning of general anesthesia, or 0.1mg/kg of liquid oxycodone via an OG tube after the procedure at the end of general anesthesia. Every patient will receive inhalational or intravenous induction of anesthesia as decided by the anesthesia team on the day of surgery, as is routine clinical care. An intravenous cannula (IV) will be inserted in every patient as part of their routine clinical care. No additional intravenous line will be required for this study. An arterial line will only be used if indicated by surgical procedure. As part of the study protocol, a blood sample (5 mL) will be taken from the IV and sent for genetic analysis. The genetic testing is specifically to analyze the following genotypes only: cytochrome P450 (CYP) 2D6 and 3A4, which represent the differences in cytochrome P450 metabolism of oxycodone. An orogastric tube will be placed in the stomach (placement verified by routine accepted clinical guidelines) under anesthesia as is part of standard routine clinical care to remove gastric contents. The same orogastric tube will be used for intragastric liquid oxycodone administration in a dose of 0.1 mg/kg either before the procedure (beginning of general anesthesia) or after the procedure (end of general anesthesia). This weight-adjusted dose of 0.1 mg/kg is administered as per standard clinical dosing guidelines at Boston Children's Hospital..
The second group will include 20 patients (children 6-8 years old). In this group the children will be randomize to either receive 0.1 mg/kg of liquid oxycodone per oral (PO) before the surgery in pre-op holding, or 0.1 mg/kg of liquid oxycodone PO after surgery in the Post Anesthesia Care Unit (PACU).
As part of routine clinical care, the anesthesiologist may give any of the following narcotics for additional pain management based on their clinical judgment: Fentanyl, sufentanil, and remifentanyl. For the purposes of this study, the following narcotics will not be administered: morphine and hydromorphone. Additionally, oxycodone will not be administered after the initial study dose in the operating room. These medications produce metabolites that would interfere with the pharmacokinetics being studied. Furthermore, morphine, hydromorphone and oxycodone will be withheld during the entire study period (up to 24 hours). This is not standard clinical care, but withholding morphine/hydromorphone/oxycodone will not result in any additional risk for the patient, since there are equally effective pain management options available which are standard of care. If the clinician deems that morphine, hydromorphone, or oxycodone is necessary for clinical care, it will not be withheld, and the patient will be withdrawn from the study.
A total of 11 blood samples will be drawn for the study. The first sample will be sent for genetic testing. The other 10 samples will be drawn at the following time points: sample 1: within 2 hours of post dose oxycodone, sample 2-7: within 30 to 90 min after last sample drawn and within 12 hours post dose oxycodone, sample 8-10: anytime between 12 to 24 hours post dose oxycodone (assigned as clinically indicated based on duration of surgery to minimize patient disturbance). Therefore, blood samples (1 mL each) will be drawn at 10 different time points in each patient. Blood for the study purposes will be drawn from the existing intravenous line or arterial line at the specific time points indicated when the child is under anesthesia. Postoperatively, regarding the timing of the blood draws, it is not necessary to be exact but rather to accurately record the time that the sample is taken. Thus, this will be coordinated with the drawing of routine laboratory tests if possible, in order to minimize patient discomfort.
- Conditions
- Liquid Oxycodone
- Being tested
- liquid oxycodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid oxycodoneDrug
The group will include 25 patients (children 2-5 years old). In this group the children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube before the procedure at the beginning of general anesthesia (after intubation).
In this group 25 children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube after the procedure at the end of general anesthesia (before extubation).
The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally before the surgery in pre-op holding.
The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally after surgery in the Post Anesthesia Care Unit (PACU).
| Study group | Role | What they receive |
|---|---|---|
| Age 2-5 years-Before GA | Active comparator | The group will include 25 patients (children 2-5 years old). In this group the children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube before the procedure at the beginning of general anesthesia (after intubation). Receives: Drug: liquid oxycodone |
| Age 2-5 years-After GA | Active comparator | In this group 25 children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube after the procedure at the end of general anesthesia (before extubation). Receives: Drug: liquid oxycodone |
| Age 6-8 years-Before GA | Active comparator | The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally before the surgery in pre-op holding. Receives: Drug: liquid oxycodone |
| Age 6-8 years-After GA | Active comparator | The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally after surgery in the Post Anesthesia Care Unit (PACU). Receives: Drug: liquid oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of general anesthesia on plasma oxycodone level in patients age 2-5 years .
Plasma oxycodone levels, at 10 time points, will be used to determine the area under the curve(AUC)
Measured: upto 24 weeks
the effect of general anesthesia on plasma oxycodone level in patients age 6-8 years
Plasma oxycodone levels, at 10 time points, will be used to determine the area under the curve(AUC)
Measured: up to 24 weeks
Secondary outcomes (12)
the effect of general anesthesia on plasma oxymorphone level in patients age 2-5 years
Plasma oxymorphone levels, at 10 time points, will be used to determine the area under the curve(AUC)
Measured: up to 2 years
the effect of general anesthesia on plasma noroxymorphone in patients age 2-5 years
Plasma noroxymorphone levels, at 10 time points, will be used to determine area under the curve(AUC)
Measured: up to 2 years
the effect of general anesthesia on plasma noroxycodone level in patients age 2-5 years
Plasma noroxycodone levels, at 10 time points, will be used to determine the area under the curve(AUC)
Measured: up to 24 weeks
the effect of general anesthesia on plasma oxymorphone level in patients age 6-8 years
Plasma oxymorphone levels, at 10 time points, will be used to determine the area under the curve(AUC)
Measured: up to 24 weeks
the effect of general anesthesia on plasma noroxymorphone in patients age 6-8 years
Plasma noroxymorphone levels, at 10 time points, will be used to determine area under the curve(AUC)
Measured: up to 24 weeks
the effect of general anesthesia on plasma noroxycodone level in patients age 6-8 years
Plasma noroxycodone levels, at 10 time points, will be used to determine the area under the curve(AUC)
Measured: up to 24 weeks
the effect of general anesthesia on plasma oxycodone level in patients age 2-5 years with respect to the pharmacogenomics.
Plasma oxycodone levels, at 10 time points, will be used to determine the area under the curve(AUC).
Measured: up to 24 weeks
the effect of general anesthesia on plasma oxycodone level in patients age 6-8 years years with respect to the pharmacogenomics.
Plasma oxycodone levels, at 10 time points, will be used to determine the area under the curve(AUC).
Measured: up to 24 weeks
the effect of general anesthesia on oxycodone absorption in patients age 2-5 years
Plasma oxycodone levels, at 10 time points, will be used to determine the onset of oxycodone absoprtion
Measured: up to 24 weeks
the effect of general anesthesia on oxycodone absorption in patients age 6-8 years
Plasma oxycodone levels, at 10 time points, will be used to determine the onset of oxycodone absoprtion
Measured: up to 24 weeks
the effect of general anesthesia on maximum plasma oxycodone level in patients age 2-5 years
Plasma oxycodone levels, at 10 time points, will be used to determine maximum plasma concentration (Cmax).
Measured: up to 24 weeks
the effect of general anesthesia on maximum plasma oxycodone level in patients age 6-8 years
Plasma oxycodone levels, at 10 time points, will be used to determine maximum plasma concentration (Cmax).
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start8 Jul 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liquid OxycodoneStudies of the same condition, open and under way.
- More trials run by Boston Children's 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patcharee Sriswasdi, Boston Children's Hospital
- Investigators
- Patcharee Sriswasdi, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054831
- Sponsor's protocol ID
- IRB-P00022355
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2016
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of General Anesthesia on Pharmacokinetics and Pharmacogenomics of Liquid Oxycodone in Pediatric Surgical Patients
- ClinicalTrials.gov ID
- NCT03054831
- Acronym / sponsor ID
- IRB-P00022355
- Conditions
- Liquid Oxycodone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Feb 2017 (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.
Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it does in the body) and pharmacodynamics (how it works) have not been well established in children. Some children, because of their specific genetic make-up, may metabolize the drug more quickly and therefore may be at risk for more side effects in the commonly prescribed dose. The investigators would like to find out more about how general anesthesia (GA) effects how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, the investigators would like to give oxycodone to surgical patients (group one will receive oxycodone at the beginning of GA and group two will receive oxycodone at the end of GA) at Boston Children's Hospital then measure its metabolic activity and also perform a specific genetic analysis.
Detailed description
This research will involve two treatment groups: (children 2-5 years old) and (children 6-8 years old). The first group will include 20 children 2-5 years old. In this group the children will be randomized to either receive 0.1mg/kg of liquid oxycodone via an orogastric (OG) tube after induction but before the procedure at the beginning of general anesthesia, or 0.1mg/kg of liquid oxycodone via an OG tube after the procedure at the end of general anesthesia. Every patient will receive inhalational or intravenous induction of anesthesia as decided by the anesthesia team on the day of surgery, as is routine clinical care. An intravenous cannula (IV) will be inserted in every patient as part of their routine clinical care. No additional intravenous line will be required for this study. An arterial line will only be used if indicated by surgical procedure. As part of the study protocol, a blood sample (5 mL) will be taken from the IV and sent for genetic analysis. The genetic testing is specifically to analyze the following genotypes only: cytochrome P450 (CYP) 2D6 and 3A4, which represent the differences in cytochrome P450 metabolism of oxycodone. An orogastric tube will be placed in the stomach (placement verified by routine accepted clinical guidelines) under anesthesia as is part of standard routine clinical care to remove gastric contents. The same orogastric tube will be used for intragastric liquid oxycodone administration in a dose of 0.1 mg/kg either before the procedure (beginning of general anesthesia) or after the procedure (end of general anesthesia). This weight-adjusted dose of 0.1 mg/kg is administered as per standard clinical dosing guidelines at Boston Children's Hospital..
The second group will include 20 patients (children 6-8 years old). In this group the children will be randomize to either receive 0.1 mg/kg of liquid oxycodone per oral (PO) before the surgery in pre-op holding, or 0.1 mg/kg of liquid oxycodone PO after surgery in the Post Anesthesia Care Unit (PACU).
As part of routine clinical care, the anesthesiologist may give any of the following narcotics for additional pain management based on their clinical judgment: Fentanyl, sufentanil, and remifentanyl. For the purposes of this study, the following narcotics will not be administered: morphine and hydromorphone. Additionally, oxycodone will not be administered after the initial study dose in the operating room. These medications produce metabolites that would interfere with the pharmacokinetics being studied. Furthermore, morphine, hydromorphone and oxycodone will be withheld during the entire study period (up to 24 hours). This is not standard clinical care, but withholding morphine/hydromorphone/oxycodone will not result in any additional risk for the patient, since there are equally effective pain management options available which are standard of care. If the clinician deems that morphine, hydromorphone, or oxycodone is necessary for clinical care, it will not be withheld, and the patient will be withdrawn from the study.
A total of 11 blood samples will be drawn for the study. The first sample will be sent for genetic testing. The other 10 samples will be drawn at the following time points: sample 1: within 2 hours of post dose oxycodone, sample 2-7: within 30 to 90 min after last sample drawn and within 12 hours post dose oxycodone, sample 8-10: anytime between 12 to 24 hours post dose oxycodone (assigned as clinically indicated based on duration of surgery to minimize patient disturbance). Therefore, blood samples (1 mL each) will be drawn at 10 different time points in each patient. Blood for the study purposes will be drawn from the existing intravenous line or arterial line at the specific time points indicated when the child is under anesthesia. Postoperatively, regarding the timing of the blood draws, it is not necessary to be exact but rather to accurately record the time that the sample is taken. Thus, this will be coordinated with the drawing of routine laboratory tests if possible, in order to minimize patient discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Age 2-5 years-Before GA | Active comparator | Drug: liquid oxycodoneThe group will include 25 patients (children 2-5 years old). In this group the children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube before the procedure at the beginning of general anesthesia (after intubation). |
| Age 2-5 years-After GA | Active comparator | Drug: liquid oxycodoneIn this group 25 children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube after the procedure at the end of general anesthesia (before extubation). |
| Age 6-8 years-Before GA | Active comparator | Drug: liquid oxycodoneThe group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally before the surgery in pre-op holding. |
| Age 6-8 years-After GA | Active comparator | Drug: liquid oxycodoneThe group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally after surgery in the Post Anesthesia Care Unit (PACU). |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- hypospadias repair
- ureteral reimplantation
- pyeloplasty (Genitourinary Surgery Service) and age between 2-8 years, and opioid naive, and not meet exclusion criteria
Key exclusion criteria (5 listed)
- currently taking cytochrome P450(CYP) 3A4 or 2D6 inhibitors/inducers
- known history of allergy to oxycodone
- known gastrointestinal, hepatic, or renal dysfunction
- known sleep apnea or impaired respiratory reserve
- speak a language other than English
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 |
|---|---|---|
| liquid oxycodoneThe group will include 25 patients (children 2-5 years old). In this group the children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube before the procedure at the beginning of general anesthesia (after intubation). In this group 25 children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube after the procedure at the end of general anesthesia (before extubation). The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally before the surgery in pre-op holding. The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally after surgery in the Post Anesthesia Care Unit (PACU). | Drug | Age 2-5 years-After GA, Age 2-5 years-Before GA, Age 6-8 years-After GA, Age 6-8 years-Before GA |
Primary outcome
the effect of general anesthesia on plasma oxycodone level in patients age 2-5 years .
Time frame: upto 24 weeks
Plasma oxycodone levels, at 10 time points, will be used to determine the area under the curve(AUC)
the effect of general anesthesia on plasma oxycodone level in patients age 6-8 years
Time frame: up to 24 weeks
Plasma oxycodone levels, at 10 time points, will be used to determine the area under the curve(AUC)
12 secondary outcomes
the effect of general anesthesia on plasma oxymorphone level in patients age 2-5 years
Time frame: up to 2 years
the effect of general anesthesia on plasma noroxymorphone in patients age 2-5 years
Time frame: up to 2 years
the effect of general anesthesia on plasma noroxycodone level in patients age 2-5 years
Time frame: up to 24 weeks
the effect of general anesthesia on plasma oxymorphone level in patients age 6-8 years
Time frame: up to 24 weeks
the effect of general anesthesia on plasma noroxymorphone in patients age 6-8 years
Time frame: up to 24 weeks
the effect of general anesthesia on plasma noroxycodone level in patients age 6-8 years
Time frame: up to 24 weeks
the effect of general anesthesia on plasma oxycodone level in patients age 2-5 years with respect to the pharmacogenomics.
Time frame: up to 24 weeks
the effect of general anesthesia on plasma oxycodone level in patients age 6-8 years years with respect to the pharmacogenomics.
Time frame: up to 24 weeks
the effect of general anesthesia on oxycodone absorption in patients age 2-5 years
Time frame: up to 24 weeks
the effect of general anesthesia on oxycodone absorption in patients age 6-8 years
Time frame: up to 24 weeks
the effect of general anesthesia on maximum plasma oxycodone level in patients age 2-5 years
Time frame: up to 24 weeks
the effect of general anesthesia on maximum plasma oxycodone level in patients age 6-8 years
Time frame: up to 24 weeks
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 22 Apr 2026.
- Individual participant dataSharing planned: Yes
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.
Patcharee Sriswasdi, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liquid oxycodone in people with Liquid Oxycodone, run by Boston Children's Hospital at 1 site in United States.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 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 United States. 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.
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?
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?
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?
the effect of general anesthesia on plasma oxycodone level in patients age 2-5 years . (time frame: upto 24 weeks). The study lists 2 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 22 Apr 2026.