PMID- 26164784
OWN - NLM
STAT- MEDLINE
DCOM- 20160509
LR  - 20181202
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 37
IP  - 8
DP  - 2015 Aug
TI  - Safety and Efficacy of a Needle-free Powder Lidocaine Delivery System in 
      Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: 
      Randomized Double-blind COMFORT-004 Trial.
PG  - 1761-72
LID - S0149-2918(15)00857-7 [pii]
LID - 10.1016/j.clinthera.2015.05.515 [doi]
AB  - PURPOSE: The goal of this study was to determine if a lidocaine hydrochloride 
      monohydrate powder intradermal system designed to provide cutaneous analgesia is 
      efficacious, safe, and tolerable for pediatric subjects compared with a sham 
      placebo system. METHODS: COMFORT-004, A Phase III, Randomized, Double-Blind, 
      Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in 
      Pediatric Subjects, was a single-dose, parallel group study of children 
      undergoing venipuncture or peripheral venous cannulation at the antecubital fossa 
      or back of the hand. Included were subjects (3-18 years) in 3 age groups: 3-7, 
      8-12, and 13-18 years. Excluded were those with recent similar procedures or with 
      implantable devices or skin pathologies at the anatomical site, insufficient 
      cognitive skills, or allergies to local anesthetics or adhesives. Subjects were 
      randomized to receive the needle-free powder lidocaine delivery system (active 
      system, 0.5 mg of lidocaine/21 +/- 1 bar of pressure [n = 269]) or sham placebo (n 
      = 266) 1-3 minutes before venipuncture or peripheral venous cannulation. 
      Analgesic efficacy was assessed patient self-report of venous access pain 
      (Wong-Baker FACES Pain Rating Scale [3-18 years] and visual analog scale [VAS; 
      8-18 years]) and parental observational VAS. Safety assessments included adverse 
      events (AEs) and relationship to study treatment. Skin signs and symptoms were 
      graded numerically. Wong-Baker FACES scores, VAS, and parental VAS were analyzed 
      by using an ANOVA model. Responder ratings and success rates were compared by 
      using a Cochran-Mantel-Haenszel test stratified according to center, age group, 
      and body site. FINDINGS: The active system group had significantly (P = 0.0022) 
      less pain compared with the sham placebo in all age groups combined according to 
      the modified Wong-Baker FACES scale. Secondary efficacy analyses found that the 
      active system resulted in less pain as assessed by subjects' VAS pain assessments 
      aged 8-18 years (P = 0.1856), responder analysis (P = 0.054), and parents' VAS 
      assessments (P = 0.002). Venous procedures were successful in 95.5% and 96.2% of 
      the active system and sham placebo groups, respectively. Treatment-emergent AEs, 
      most commonly nausea and/or emesis, were not significant between groups. There 
      were no serious AEs. The active system group had significantly more minor 
      erythema and hemorrhage/petechiae. IMPLICATIONS: The needle-free powder lidocaine 
      delivery system was well tolerated and produced superior analgesia compared with 
      sham placebo when administered 1-3 minutes before pediatric venipuncture or 
      peripheral venous cannulation. Treatment-related AEs occurred primarily at the 
      administration site and were infrequent, generally mild, and resolved without 
      sequelae. ClinicalTrials.gov identifier: NCT00140088.
CI  - Copyright (c) 2015 Elsevier HS Journals, Inc. All rights reserved.
FAU - Schmitz, Michael L
AU  - Schmitz ML
AD  - Arkansas Children׳s Hospital, Little Rock, Arkansas. Electronic address: 
      schmitzmichaell@uams.edu.
FAU - Zempsky, William T
AU  - Zempsky WT
AD  - Connecticut Children's Medical Center, Hartford, Connecticut.
FAU - Meyer, James M
AU  - Meyer JM
AD  - Marathon Pharmaceuticals, LLC, Northbrook, Illinois.
LA  - eng
SI  - ClinicalTrials.gov/NCT00140088
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150708
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Anesthetics, Local)
RN  - 0 (Powders)
RN  - 98PI200987 (Lidocaine)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Anesthetics, Local/*administration & dosage
MH  - Catheterization, Peripheral/*methods
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Lidocaine/*administration & dosage
MH  - Male
MH  - Needles
MH  - Pain/prevention & control
MH  - Pain Management
MH  - Pain Measurement/methods
MH  - Phlebotomy/*methods
MH  - Powders
OTO - NOTNLM
OT  - adolescent
OT  - child
OT  - lidocaine
OT  - pain assessment
OT  - peripheral cannulation
OT  - transdermal administration
OT  - venipuncture
EDAT- 2015/07/15 06:00
MHDA- 2016/05/10 06:00
CRDT- 2015/07/13 06:00
PHST- 2014/12/28 00:00 [received]
PHST- 2015/03/30 00:00 [revised]
PHST- 2015/05/27 00:00 [accepted]
PHST- 2015/07/13 06:00 [entrez]
PHST- 2015/07/15 06:00 [pubmed]
PHST- 2016/05/10 06:00 [medline]
AID - S0149-2918(15)00857-7 [pii]
AID - 10.1016/j.clinthera.2015.05.515 [doi]
PST - ppublish
SO  - Clin Ther. 2015 Aug;37(8):1761-72. doi: 10.1016/j.clinthera.2015.05.515. Epub 
      2015 Jul 8.