Emergence DeliriumNCT03778372
Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
An observational study of Emergence Delirium and Strabismus, run by Ochsner Health System at 1 site in United States.
Trial summary
Strabismus surgery for children is a very common procedure, with a high incidence of emergence delirium in the recovery room. Pain is often implicated in delirium. The primary aim of this study is to determine whether a single, intraoperative dose of methadone for outpatient ambulatory pediatric strabismus surgery… Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium, Strabismus
- What is being tested?
- Methadone
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 13 Dec 2020
- Phase
- Observational
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy children, aged 0-18 years, undergoing outpatient strabismus surgery under general anesthesia
Who may be able to join
- ASA I/II children undergoing outpatient strabismus surgery
Who cannot join
- anything not meeting the above
Trial locations and contacts
1 site in 1 country.
About this study
Strabismus surgery for children is a very common procedure, with a high incidence of emergence delirium in the recovery room. Pain is often implicated in delirium. The primary aim of this study is to determine whether a single, intraoperative dose of methadone for outpatient ambulatory pediatric strabismus surgery reduces postoperative delirium.
- Conditions
- Emergence Delirium, Strabismus
- Being tested
- Methadone
- Medical subject headings
- Emergence Delirium, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
see desc above
| Study group | Role | What they receive |
|---|---|---|
| study | pediatric patients undergoing outpatient strabismus surgery, and receiving methadone Receives: Drug: Methadone | |
| control | pediatric patients undergoing outpatient strabismus surgery, and not receiving methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium scale scores
A low total score would indicate less emergence delirium
Measured: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
Secondary outcomes (2)
wong-baker or numeric pain scores, depending on age
A low total score would indicate less pain
Measured: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
discharge time
time the patient is actually discharged from recovery room
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2019
- Primary completion13 Dec 2020
- Study completion13 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Dajani, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778372
- Sponsor's protocol ID
- Pro00014855
- Status last verified
- Jul 2022
- First submitted
- 11 Dec 2018
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.
PubMed 29847382Ward RM, Drover DR, Hammer GB, Stemland CJ, Kern S, Tristani-Firouzi M, Lugo RA, Satterfield K, Anderson BJ. The pharmacokinetics of methadone and its metabolites in neonates, infants, and children. Paediatr Anaesth. 2014 Jun;24(6):591-601. doi: 10.1111/pan.12385. Epub 2014 Mar 26.
PubMed 24666686
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
- ClinicalTrials.gov ID
- NCT03778372
- Acronym / sponsor ID
- Pro00014855
- Conditions
- Emergence Delirium, Strabismus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 13 Dec 2020 (actual)
- Study completion
- 13 Dec 2020 (actual)
- First posted
- 19 Dec 2018 (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.
Strabismus surgery for children is a very common procedure, with a high incidence of emergence delirium in the recovery room. Pain is often implicated in delirium. The primary aim of this study is to determine whether a single, intraoperative dose of methadone for outpatient ambulatory pediatric strabismus surgery reduces postoperative delirium.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | – | Drug: Methadonepediatric patients undergoing outpatient strabismus surgery, and receiving methadone |
| control | – | –pediatric patients undergoing outpatient strabismus surgery, and not receiving methadone |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy children, aged 0-18 years, undergoing outpatient strabismus surgery under general anesthesia
Key inclusion criteria (1 listed)
- ASA I/II children undergoing outpatient strabismus surgery
Key exclusion criteria (1 listed)
- anything not meeting the above
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 |
|---|---|---|
| Methadonesee desc above | Drug | study |
Primary outcome
Pediatric Anesthesia Emergence Delirium scale scores
Time frame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
A low total score would indicate less emergence delirium
2 secondary outcomes
wong-baker or numeric pain scores, depending on age
Time frame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
discharge time
Time frame: 24 hours
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 19 Jul 2022.
- Background: PubMed 29847382Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.
- Background: PubMed 24666686Ward RM, Drover DR, Hammer GB, Stemland CJ, Kern S, Tristani-Firouzi M, Lugo RA, Satterfield K, Anderson BJ. The pharmacokinetics of methadone and its metabolites in neonates, infants, and children. Paediatr Anaesth. 2014 Jun;24(6):591-601. doi: 10.1111/pan.12385. Epub 2014 Mar 26.
- 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?
An observational study of Emergence Delirium and Strabismus, run by Ochsner Health System 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 1 inclusion and 1 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 19 Jul 2022. 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.
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?
Pediatric Anesthesia Emergence Delirium scale scores (time frame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 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 NCT03778372, which also lists 2 linked publications.
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 19 Jul 2022.