N/A
N=115
Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy
Knee Injury
Bottom Line
View on ClinicalTrials.gov: NCT02649322 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale. — .25; .43 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- J-Tip (Device); Syringe and 25 gauge needle (Device)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Orlando Health, Inc.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale. |
.25; .43 | — |
| PRIMARY Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale |
1.54; 3.57 | — |
| SECONDARY Satisfaction Via a 0 to 10 Rating Scale at Follow up |
2.384615385; 2.391304348 | — |
Summary
Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected lidocaine prior to regional and general anesthesia.
Eligibility Criteria
Inclusion Criteria
Subjects between the ages of eleven and seventeen undergoing arthroscopic knee surgery.
- Able to independently complete the Visual Analog pain scales.
- Subjects who are neurologically intact at area of injection.
- English speaking.
Exclusion Criteria
- Subjects with known allergies to lidocaine.
- Presence of developmental delay.
- Subjects with blood disorders affecting coagulation.
- Subjects on blood thinners.
- Subjects receiving chemotherapeutic agents.
- Those who use or receive analgesia prior to procedure, except for acetaminophen or Non-steroidal anti-inflammatory medications.
- Any other local sedation at the area of nerve block injection.
- Non-English Speaking
- Subjects with signs of skin infection or pathology at the injection site.
Data sourced from ClinicalTrials.gov (NCT02649322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.