None listed
Conditions
Interventions
Procedure/Surgery : The iliac bone was harvested using a standardized surgical approach in all patients, and intravenous acetaminophen was administered to all patients at the end of surgery under gene
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Children aged 6 to 10 years - Patients scheduled to undergo alveolar bone grafting, including iliac crest bone harvest, due to cleft lip and/or palate - Patients whose legal guardians have received a full explanation of the study and have provided written informed consent - Patients classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II, with no preoperative ambulatory impairment - Patients who score 18 points or higher on the preoperative Neurocognitive Screening Test, indicating adequate ability for self-reporting of pain
Exclusion criteria
Exclusion criteria: - History of allergy or hypersensitivity to local anesthetics - Presence of neuromuscular disorders, developmental delay, or neurological conditions that impair the ability to express pain - Presence of chronic pain conditions or ongoing use of opioids prior to surgery - Altered pelvic anatomy due to previous surgical history - Active skin infection at the planned procedure site Presence of other systemic congenital anomalies or syndromes Presence of bleeding disorders or current use of anticoagulant therapy Any other condition that, in the investigator’s judgment, makes the patient unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total opioid consumption will be assessed by collecting the amount of narcotic analgesic (fentanyl) administered during the first 24 hours postoperatively. This will be converted into intravenous morphine equivalents (mg/kg) for analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain scores at the iliac crest donor site will be assessed using the Faces Pain Scale–Revised (FPS-R) at 1, 6, 12, and 24 hours after surgery.;Anchor reports will be conducted at 1, 6, 12, and 24 hours after surgery (e.g., “Is your pain better or worse compared to before analgesic administration?”).;The time (in minutes) from the end of surgery to the first request for additional (rescue) analgesia for pain control will be recorded.;Functional Recovery Outcomes: - Daily step counts on postoperative days 1 and 2 will be collected using an activity tracker - Time (in minutes) from the end of surgery to the first successful independent ambulation (defined as at least 5 steps without assistance) - Maximum pain score at the iliac crest donor site (FPS-R) immediately after performing a designated activity (e.g., walking | — |
Countries
Korea, Republic of
Contacts
Public ContactTAE SUK OH
Asan Medical Center
Outcome results
None listed