Scoliosis Scoliosis
Conditions
Interventions
This study is a single-arm interventional study that investigates the use of a diclofenac sodium transdermal absorption formulation during the perioperative period to assess its safety.
Sponsors
Uotani Koji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The criteria for inclusion in this study are as follows: Individuals aged 12 to under 15 at the time of consent, regardless of gender. Individuals who, after receiving adequate explanation regarding participation in this study, can provide assent, as well as those whose legally authorized representatives have provided written informed consent. Target diseases: Adolescent Scoliosis
Exclusion criteria
Exclusion criteria: Individuals meeting any of the following criteria will be excluded from the study: Patients with renal dysfunction, defined as a preoperative serum creatinine level of >=1.2 mg/dL Cases with a known allergy to diclofenac sodium. Individuals with aspirin-induced asthma or a history thereof. Patients deemed unsuitable for the study by the principal investigator or co-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of postoperative renal dysfunction | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of additional analgesic administrations, number of PCA uses Temporal changes in pain scores (NRS) Days until the initiation of postoperative ambulation All adverse events excluding renal impairment. | — |
Contacts
Public ContactKoji Uotani
Okayama University
Outcome results
None listed