Correctional Osteotomy
Conditions
Brief summary
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.
Interventions
bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device
Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
triple (Participant, Care Provider, investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Pediatric patients with between 4 and 13 years * 2\. Patients scheduled for correctional osteotomy of the lower extremity * 3\. Pediatric patients whose weight of 40kg of less
Exclusion criteria
* 1\. Contraindications to epidural analgesia (local infection, blood clotting disorder, anatomical abnormality, sepsis, etc.) * 2\. Patients with symptoms/signs of elevated intracranial pressure with or without a history of elevated intracranial pressure * 3\. If all of the parents of the subject are foreigners or illiterate (if the parents of the subject can not read the agreement)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in total amount of ropivacaine injected through epidural analgesia | 6 hours after surgery | The difference in the amount of ropivacaine injected into epidural space for 6 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient-controlled rescue epidural bolus for 48 hours postoperatively | 48 hours after surgery | — |
| Pain scores for 6 hours after surgery (VAS) | 6 hours after surgery | VAS(visual analogue scale) :0(no paine)\ 10(wort possible, unbearable, excruciating apin) |
| Pain scores for 12 hours after surgery (VAS) | 12 hours after surgery | VAS(visual analogue scale) :0(no paine)\ 10(wort possible, unbearable, excruciating apin) |
| Pain scores for 24 hours after surgery (VAS) | 24 hours after surgery | VAS(visual analogue scale) :0(no paine)\ 10(wort possible, unbearable, excruciating apin) |
| Pain scores for 48 hours after surgery (VAS) | 48 hours after surgery | VAS(visual analogue scale) :0(no paine)\ 10(wort possible, unbearable, excruciating apin) |
| The time for the first patient controlled rescue epidural bolus after surgery | 48 hours after surgery | — |
| Pain scores for 12 hours after surgery (r-FLACC) | 12 hours after surgery | 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. |
| Pain scores for 24 hours after surgery (r-FLACC) | 24 hours after surgery | 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. |
| Pain scores for 48 hours after surgery (r-FLACC) | 48 hours after surgery | 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. |
| Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. | 48 hours after surgery | -% of patients with given intravenous additional narcotic analgesics * number of administrating intravenous additional narcotic analgesics per patient |
| A dull feeling the patient feels | 6 hours after surgery | A dull feeling the patient feels : yes or no |
| Pain scores for 6 hours after surgery (r-FLACC) | 6 hours after surgery | 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. |
Countries
South Korea
Contacts
Primary ContactYong Seon Choi, MD., PhD.
Outcome results
None listed