N/A
N=205
The Use of Jet Injection Lidocaine for Blood Draws in Young Children
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01890642 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture — 1.71; 2.82; 0.23 units on a scale — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- J tip (Device); Pain Ease Spray (Other); 1% buffered lidocaine (Drug); placebo cooling spray (normal saline spray) (Other); Sucrose (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture |
1.71; 2.82; 0.23 | 0.0001 sig |
| SECONDARY Pain Score |
5.75; 8; 5.25 | 0.01 sig |
| SECONDARY Fist Attempt Success |
52; 48; 86 | 0.80 |
| SECONDARY Change in Pain Score From Baseline |
2.32; 3.7; 1.58 | 0.004 sig |
| SECONDARY Pain at J-tip Deployment |
3.25; 2.5; 4.0 | 0.37 |
Summary
This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in children ages 6 and younger. The investigators will use video observation of patients to asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain Ease spray 3) Pain Ease spray plus the J tip noise.
Eligibility Criteria
Inclusion Criteria
- Children aged 6 months-6 years seen in the Children's Hospital of Wisconsin outpatient laboratory that have an order for venipuncture for a blood draw
Exclusion Criteria
- Previous adverse reaction to lidocaine or Pain Ease spray
- Pre-existing skin lesion at site of blood draw
- Needle stick for IV insertion or lab draw that has already occurred at current hospital visit
- Patients who are physically unable to move their arms or legs
- Patients who are unable to cry
- Patients with connective tissue disorders that predispose to easy bruising
- Patients with bleeding disorders
Data sourced from ClinicalTrials.gov (NCT01890642). 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.