Adolescent Idiopathic Scoliosis, Postoperative Pain, Respiratory Depression
Conditions
Keywords
Adolescent Idiopathic Scoliosis, Scoliosis surgery, Pharmacokinetic simulation
Brief summary
The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid respiratory depression and allow patients to respond quickly either during intraoperative testing or at the conclusion of surgery.
Detailed description
As part of this study, anesthesiologists will be given additional data on the expected drug effects based on a computer simulation. The data will be provided as a suggestion and will be used together with all the other information normally used to keep the study subjects safely asleep during surgery. In addition, data will be collected from the medical history and on postoperative pain control and medication side effects for the first 24 hours. Specifically, study subjects will be asked to rate their pain on a 10-point scale after they wake up from surgery and once they arrive in the pediatric intensive care unit. Measures of the time from the end of surgery until the study subjects are awake and out of the operating room will also be collected.
Interventions
OTHERpharmacokinetic simulation
The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) class 1-2 * At least 10 years of age and not older than 18 years of age * Diagnosis of idiopathic adolescent scoliosis
Exclusion criteria
* Currently pregnant * Currently breastfeeding * Currently being treated with opiates * Currently being treated with alpha2 agonists * Currently being treated with anticonvulsants * Currently being treated with antidepressants * History of significant restrictive lung disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 4-Item Pain Intensity Measure | 24 hours | 0 - 10 (0=no pain; 10 = pain as bad as can be) |
| Respiratory depression | 24 hours | Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utility of pharmacokinetic simulation | 4 - 8 hours (Intraoperative period) | The number of modifications to the anesthetic dosing |
Countries
United States
Outcome results
None listed