Anesthesia
Conditions
Keywords
Pediatric patients undergoing surgery
Brief summary
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.
Interventions
DRUGMethadone 0.1mg/kg
Subjects will receive methadone as their intraoperative opioid.
DRUGMethadone 0.2mg/kg
Subjects will receive methadone as their intraoperative opioid.
DRUGMethadone 0.3mg/kg
Subjects will receive methadone as their intraoperative opioid.
DRUGControl
Subjects will not receive methadone as their intraoperative opioid.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 5-18 * Undergoing General anesthesia and surgery with anticipated postoperative inpatient stay of greater than or equal to 3 days * Signed, written, informed consent from legal guardians and assent from patient
Exclusion criteria
* History of or known liver or kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R-methadone Plasma AUC 0-96hr/Dose | 96 hr |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methadone 0.1mg/kg Subjects will receive methadone as their intraoperative opioid. | 10 |
| Methadone 0.2mg/kg Subjects will receive methadone as their intraoperative opioid. | 10 |
| Methadone 0.3mg/kg Subjects will receive methadone as their intraoperative opioid. | 11 |
| Control Subjects do not receive methadone as their intraoperative opioid. | 30 |
| Total | 61 |
Baseline characteristics
| Characteristic | Total | Methadone 0.2mg/kg | Methadone 0.3mg/kg | Control | Methadone 0.1mg/kg |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 61 Participants | 10 Participants | 11 Participants | 30 Participants | 10 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United States | 61 Participants | 10 Participants | 11 Participants | 30 Participants | 10 Participants |
| Sex: Female, Male Female | 42 Participants | 4 Participants | 9 Participants | 21 Participants | 8 Participants |
| Sex: Female, Male Male | 19 Participants | 6 Participants | 2 Participants | 9 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 30 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 30 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 30 |
Outcome results
Primary
R-methadone Plasma AUC 0-96hr/Dose
Time frame: 96 hr
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methadone 0.1mg/kg | R-methadone Plasma AUC 0-96hr/Dose | 228 (ng * hr-1 * ml-1 * mg-1 | Standard Deviation 164 |
| Methadone 0.2mg/kg | R-methadone Plasma AUC 0-96hr/Dose | 189 (ng * hr-1 * ml-1 * mg-1 | Standard Deviation 54 |
| Methadone 0.3mg/kg | R-methadone Plasma AUC 0-96hr/Dose | 205 (ng * hr-1 * ml-1 * mg-1 | Standard Deviation 102 |
| Control | R-methadone Plasma AUC 0-96hr/Dose | 0 (ng * hr-1 * ml-1 * mg-1 | Standard Deviation 0 |
p-value: <0.05ANOVA