Pain, AcutePhase 3METACEBONCT04680286
Intraoperative Methadone in Children Undergoing Surgery
A Phase 3 study testing Methadone Hydrochloride in people with Pain, Acute and Pain, Postoperative, run by University of Aarhus at 1 site in Denmark.
Trial summary
A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in 96 children undergoing open urological surgery. Read more about this study
- Who is it for?
- Ages 0 to 4 years, men only
- Conditions the study is for
- Pain, Acute, Pain, Postoperative, Children, Only
- What is being tested?
- Methadone Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Nov 2020to 1 Feb 2024
- Phase
- Phase 3
- 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 0 to 4 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled for open urological surgery at the Outpatient Clinic at Aarhus University Hospital.
Who cannot join
- Age =/> 5 years at the date of operation
- Born preterm (Before gestational age of 37 weeks)
- Congenital heart disease
- Previous scrotal surgery
- Laparoscopic operation
- American Society of Anaesthesiologists (ASA) physical status lll, IV or V
Show all 13Show fewer
- Allergy to study drugs
- Preoperative daily use of opioids
- Parents with inability to provide informed consent
- Severe respiratory insufficiency
- Acute abdominal pain
- Severe kidney insufficiency
- Treatment with rifampicin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Intraoperative Methadone in Children Undergoing Open Urological Surgery: a Randomized, Double-blind Trial
A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in 96 children undergoing open urological surgery.
Read the detailed description
Treatment of postoperative pain is a challenge in younger children undergoing outpatient surgery. After discharge parents must assess pain intensity and administer analgesics, including opioids, as per needed. It has been shown that parents often hesitate to administer analgesics. The result is unrelieved pain that negatively affects the whole family and increases the risk of unscheduled contacts with healthcare professionals.
In children, methadone has shown a half-life of 19,2 +/-13,6 hours. Regarding outpatient surgery, methadone is an opioid with unique pharmalogical properties that may be advantageous. A single-dose of this long acting opioid administered perioperatively could provide a stable analgesia and potentially reduce the need for shorter-acting opioids in the PACU and at home.
- Conditions
- Pain, Acute, Pain, Postoperative, Children, Only
- Being tested
- Methadone Hydrochloride, Placebo
- Keywords
- methadone, analgesics, opioids, postoperative, placebo
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone HydrochlorideDrug
Also called Methadone
Single dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia.
PlaceboOther
Also called Saline
Single dose, intravenous bolus. Administered as the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A 5 ml syringe with saline will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia. Receives: Other: Placebo |
| Methadone | Experimental | A 5 ml syringe with 1 mg/ml of methadone will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia. Receives: Drug: Methadone Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients consumption of analgesics in the PACU.
Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours).
Measured: 3 hours
Pain intensity (highest score)
FLACC-score - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score. Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours)
Measured: 3 hours
Secondary outcomes (6)
Readiness to discharge
Time for readiness to discharge from PACU assessed by PACU nurse.
Measured: 6 hours
Patients need of supplemental oxygen in PACU
Need of supplemental oxygen within the first 3 hours after extubation,(or until discharge from PACU, if discharged before 3 hours)
Measured: 3 hours
Awakenings during the first night after discharge.
Parents will answer whether the child have been awake and whether they believe the awakening(s) where due to pain.
Measured: 24 hours
Pain intensity the first postoperative day
Assessed by parents, 3 FLACC-scores - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score, during the first postoperative day.
Measured: 48 hours
Analgesic consumption following discharge until evening on the first postoperative day
From discharge until 8 PM the first day following surgery. Collected by parents.
Measured: 36 hours
Unscheduled parental contacts to the hospital
Parental contacts to hospital regarding pain and/or analgesics until 4 days following surgery.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start16 Nov 2020
- Primary completion30 Jan 2024
- Study completion1 Feb 2024
Why it stopped: Slow recruitment due to covid-19 and organizational changes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680286
- Sponsor's protocol ID
- 23956082
- Other IDs
- 2020-002945-41
- Acronym
- METACEBO
- Status last verified
- Apr 2023
- First submitted
- 11 Dec 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intraoperative Methadone in Children Undergoing Open Urological Surgery: a Randomized, Double-blind Trial
- ClinicalTrials.gov ID
- NCT04680286
- Acronym / sponsor ID
- METACEBO / 23956082
- Conditions
- Pain, Acute, Pain, Postoperative, Children, Only
- Keywords
- methadone, analgesics, opioids, postoperative, placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment due to covid-19 and organizational changes.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 22 Dec 2020 (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.
A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in 96 children undergoing open urological surgery.
Detailed description
Treatment of postoperative pain is a challenge in younger children undergoing outpatient surgery. After discharge parents must assess pain intensity and administer analgesics, including opioids, as per needed. It has been shown that parents often hesitate to administer analgesics. The result is unrelieved pain that negatively affects the whole family and increases the risk of unscheduled contacts with healthcare professionals.
In children, methadone has shown a half-life of 19,2 +/-13,6 hours. Regarding outpatient surgery, methadone is an opioid with unique pharmalogical properties that may be advantageous. A single-dose of this long acting opioid administered perioperatively could provide a stable analgesia and potentially reduce the need for shorter-acting opioids in the PACU and at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboA 5 ml syringe with saline will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia. |
| Methadone | Experimental | Drug: Methadone HydrochlorideA 5 ml syringe with 1 mg/ml of methadone will be prepared and study drug will be administered as intravenous bolus dose (0.1 mg/kg). The study drug will be administered at induction of anesthesia. |
Who may qualify
- Ages
- 0 to 4 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children scheduled for open urological surgery at the Outpatient Clinic at Aarhus University Hospital.
Key exclusion criteria (13 listed)
- Age =/> 5 years at the date of operation
- Born preterm (Before gestational age of 37 weeks)
- Congenital heart disease
- Previous scrotal surgery
- Laparoscopic operation
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 |
|---|---|---|
| Methadone HydrochlorideAlso: MethadoneSingle dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia. | Drug | Methadone |
| PlaceboAlso: SalineSingle dose, intravenous bolus. Administered as the experimental arm. | Other | Placebo |
Primary outcome
Patients consumption of analgesics in the PACU.
Time frame: 3 hours
Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours).
Pain intensity (highest score)
Time frame: 3 hours
FLACC-score - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score. Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours)
6 secondary outcomes
Readiness to discharge
Time frame: 6 hours
Patients need of supplemental oxygen in PACU
Time frame: 3 hours
Awakenings during the first night after discharge.
Time frame: 24 hours
Pain intensity the first postoperative day
Time frame: 48 hours
Analgesic consumption following discharge until evening on the first postoperative day
Time frame: 36 hours
Unscheduled parental contacts to the hospital
Time frame: 4 days
Results and safety
The study was stopped early (reason given: Slow recruitment due to covid-19 and organizational changes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone Hydrochloride in people with Pain, Acute and Pain, Postoperative, run by University of Aarhus at 1 site in Denmark.
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 13 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: stopped early, as of the sponsor's last update on 28 Feb 2024. 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 Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment due to covid-19 and organizational changes.). Results are not available in the source record.
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?
Patients consumption of analgesics in the PACU. (time frame: 3 hours). 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 28 Feb 2024.