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The aim of this study was to compare the efficacy of a programmed intermittent bolus injection method compared to conventional continuous infusion in the management of epidural analgesia in pediatric patients correctional osteotomy. As a prospective double blinded randomized controlled trial, the investigators compare the quality of pain control after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIEB (Programmed intermittent epidural bolus) | Experimental | bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) |
|
| CEI (Continuous epidural infusion) | Active Comparator | Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Programmed intermittent epidural bolus | Device | bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in total amount of ropivacaine injected through epidural analgesia | The difference in the amount of ropivacaine injected into epidural space for 6 hours postoperatively | 6 hours after surgery |
| Difference in total amount of ropivacaine injected through epidural analgesia | The difference in the amount of ropivacaine injected into epidural space for 12 hours postoperatively | 12 hours after surgery |
| Difference in total amount of ropivacaine injected through epidural analgesia | The difference in the amount of ropivacaine injected into epidural space for 24 hours postoperatively | 24 hours after surgery |
| Difference in total amount of ropivacaine injected through epidural analgesia | The difference in the amount of ropivacaine injected into epidural space for 36 hours postoperatively | 36 hours after surgery |
| Difference in total amount of ropivacaine injected through epidural analgesia | The difference in the amount of ropivacaine injected into epidural space for 48 hours postoperatively | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The time for the first patient controlled rescue epidural bolus after surgery | 48 hours after surgery | |
| Number of patient-controlled rescue epidural bolus for 48 hours postoperatively | 48 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Seon Choi, MD., PhD. | Contact | 82-2-2228-2412 | YSCHOI@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine | Seoul | 03722 | South Korea |
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triple (Participant, Care Provider, investigator)
|
| Continuous epidural infusion | Device | Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device |
|
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| Pain scores for 6 hours after surgery (VAS) | VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin) | 6 hours after surgery |
| Pain scores for 12 hours after surgery (VAS) | VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin) | 12 hours after surgery |
| Pain scores for 24 hours after surgery (VAS) | VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin) | 24 hours after surgery |
| Pain scores for 48 hours after surgery (VAS) | VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin) | 48 hours after surgery |
| Pain scores for 6 hours after surgery (r-FLACC) | r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain. | 6 hours after surgery |
| Pain scores for 12 hours after surgery (r-FLACC) | r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain. | 12 hours after surgery |
| Pain scores for 24 hours after surgery (r-FLACC) | r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain. | 24 hours after surgery |
| Pain scores for 48 hours after surgery (r-FLACC) | r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain. | 48 hours after surgery |
| Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. | -% of patients with given intravenous additional narcotic analgesics
| 48 hours after surgery |
| Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. | -% of patients with given intravenous additional narcotic analgesics
| 48 hours after surgery |
| Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. | -% of patients with given intravenous additional narcotic analgesics
| 48 hours after surgery |
| A dull feeling the patient feels | A dull feeling the patient feels : yes or no | 6 hours after surgery |
| A dull feeling the patient feels | A dull feeling the patient feels : yes or no | 12 hours after surgery |
| A dull feeling the patient feels | A dull feeling the patient feels : yes or no | 24 hours after surgery |
| A dull feeling the patient feels | A dull feeling the patient feels : yes or no | 48 hours after surgery |