NCT01628874

Brief Summary

The purpose of this study is to evaluate the effectiveness of a needle-free jet-injection system with 1% buffered lidocaine for local anesthesia for lumbar punctures compared to a topical anesthetic agent. Our hypothesis is: A needle-free jet-injection system (J-Tip) with 1% lidocaine will provide local anesthesia that is comparable to that of a topical anesthetic agent (EMLA cream) when performing lumbar punctures in children.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

June 21, 2019

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

3.9 years

First QC Date

June 25, 2012

Results QC Date

February 20, 2019

Last Update Submit

June 19, 2019

Conditions

Lumbar PunctureTopical Analgesia

Keywords

Lumbar PunctureJ-TipJet injectionLocal Analgesia

Outcome Measures

Primary Outcomes (3)

  • Pain Score

    The pain score was assessed using the 5-point Neonatal Coding System (NFCS) on a scale of 0-5, with 0 indicating no pain and 5 the highest level of pain.

    Immediately Post-Procedure

  • Pain Score

    The pain score was assessed using the 5-point Neonatal Coding System (NFCS) on a scale of 0-5, with 0 indicating no pain and 5 the highest level of pain.

    At Needle Insertion

  • Pain Score

    The pain score was assessed using the 5-point Neonatal Coding System (NFCS) on a scale of 0-5, with 0 indicating no pain and 5 the highest level of pain.

    At time J-TIP is used

Secondary Outcomes (2)

  • Number of Participants With Lumbar Puncture Success

    Immediately following lumbar puncture

  • Change in Heart Rate

    At 5 specific points during the procedure

Study Arms (2)

Lidocaine Injection

EXPERIMENTAL

0.5 mL (5mg) of 1% lidocaine injection given with the J-Tip

Device: J-TipDrug: EMLADrug: Lidocaine

lidocaine 2.5% and prilocaine 2.5% (EMLA) Cream

ACTIVE COMPARATOR

Patients in this arm will receive 1g EMLA cream if they are in the younger age group and 10g EMLA cream if they are in the older age group. This will be placed for a minimum of 30 minutes.

Device: J-TipDrug: EMLADrug: Lidocaine

Interventions

J-TipDEVICE

Used once for both arms prior to lumbar puncture. The Experimental arm will receive 0.5 mL (5mg) of 1% Lidocaine. The Active Comparator arm will receive normal saline. This will occur after the cream has been placed for 30 minutes and wiped away and prior to the lumbar puncture.

Also known as: Needle-free jet-injection system
Lidocaine Injectionlidocaine 2.5% and prilocaine 2.5% (EMLA) Cream
EMLADRUG

In the Active Comparator arm, lidocaine 2.5% and prilocaine 2.5% cream placed over area where lumbar puncture will occur for at least 30 minutes. This same procedure will occur for the Experimental arm with a placebo cream instead. This will occur once prior to the J-Tip injection and lumbar puncture.

Also known as: EMLA Cream
Lidocaine Injectionlidocaine 2.5% and prilocaine 2.5% (EMLA) Cream
LidocaineDRUG

5 mg given via J-Tip once, repeat dosing as needed in the Experimental group. A placebo will be given in the Active Comparator group.

Lidocaine Injectionlidocaine 2.5% and prilocaine 2.5% (EMLA) Cream

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age ≤4 months or 4-18 years
  • ability to report VAS for patients 4-18 years
  • require lumbar puncture as part of their clinical care

You may not qualify if:

  • ages 5-47 months
  • developmental delay or inability to complete VAS in older patients
  • allergy to lidocaine
  • requirement of sedation for procedure
  • pre-procedural analgesia treatment except for nonsteroidal anti-inflammatory drugs and acetaminophen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (13)

  • Fein D, Avner JR, Khine H. Pattern of pain management during lumbar puncture in children. Pediatr Emerg Care. 2010 May;26(5):357-60. doi: 10.1097/PEC.0b013e3181db2026.

    PMID: 20404782BACKGROUND

  • Baxter AL, Welch JC, Burke BL, Isaacman DJ. Pain, position, and stylet styles: infant lumbar puncture practices of pediatric emergency attending physicians. Pediatr Emerg Care. 2004 Dec;20(12):816-20. doi: 10.1097/01.pec.0000148030.99339.fe.

    PMID: 15572969BACKGROUND

  • Spanos S, Booth R, Koenig H, Sikes K, Gracely E, Kim IK. Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial. Pediatr Emerg Care. 2008 Aug;24(8):511-5. doi: 10.1097/PEC.0b013e31816a8d5b.

    PMID: 18645542BACKGROUND

  • Quinn M, Carraccio C, Sacchetti A. Pain, punctures, and pediatricians. Pediatr Emerg Care. 1993 Feb;9(1):12-4. doi: 10.1097/00006565-199302000-00005. No abstract available.

    PMID: 8488137BACKGROUND

  • Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.

    PMID: 20921070BACKGROUND

  • Baxter AL, Fisher RG, Burke BL, Goldblatt SS, Isaacman DJ, Lawson ML. Local anesthetic and stylet styles: factors associated with resident lumbar puncture success. Pediatrics. 2006 Mar;117(3):876-81. doi: 10.1542/peds.2005-0519.

    PMID: 16510670BACKGROUND

  • Powell CV, Kelly AM, Williams A. Determining the minimum clinically significant difference in visual analog pain score for children. Ann Emerg Med. 2001 Jan;37(1):28-31. doi: 10.1067/mem.2001.111517.

    PMID: 11145767BACKGROUND

  • Nigrovic LE, Kuppermann N, Neuman MI. Risk factors for traumatic or unsuccessful lumbar punctures in children. Ann Emerg Med. 2007 Jun;49(6):762-71. doi: 10.1016/j.annemergmed.2006.10.018. Epub 2007 Feb 23.

    PMID: 17321005BACKGROUND

  • Jimenez N, Bradford H, Seidel KD, Sousa M, Lynn AM. A comparison of a needle-free injection system for local anesthesia versus EMLA for intravenous catheter insertion in the pediatric patient. Anesth Analg. 2006 Feb;102(2):411-4. doi: 10.1213/01.ane.0000194293.10549.62.

    PMID: 16428534BACKGROUND

  • Kaur G, Gupta P, Kumar A. A randomized trial of eutectic mixture of local anesthetics during lumbar puncture in newborns. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1065-70. doi: 10.1001/archpedi.157.11.1065.

    PMID: 14609894BACKGROUND

  • Rushforth JA, Levene MI. Behavioural response to pain in healthy neonates. Arch Dis Child Fetal Neonatal Ed. 1994 May;70(3):F174-6. doi: 10.1136/fn.70.3.f174.

    PMID: 8198409BACKGROUND

  • Grunau RVE, Craig KD. Pain expression in neonates: facial action and cry. Pain. 1987 Mar;28(3):395-410. doi: 10.1016/0304-3959(87)90073-X.

    PMID: 3574966BACKGROUND

  • Caltagirone R, Raghavan VR, Adelgais K, Roosevelt GE. A Randomized Double Blind Trial of Needle-free Injected Lidocaine Versus Topical Anesthesia for Infant Lumbar Puncture. Acad Emerg Med. 2018 Mar;25(3):310-316. doi: 10.1111/acem.13351. Epub 2017 Dec 26.

    PMID: 29160002DERIVED

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug CombinationLidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsPrilocaineAniline CompoundsAminesDrug CombinationsPharmaceutical Preparations

Limitations and Caveats

Low enrollment leading to small number of subjects analyzed; Low enrollment of older age range (4 years-18 years) leading to termination of that study arm prior to analysis (6 subjects excluded from analysis, no data for VAS collected).

Results Point of Contact

Title
Dr. Ryan Caltagirone
Organization
Children's Hospital Colorado
ryan.caltagirone@childrenscolorado.org
303-521-8563

Study Officials

  • Ryan Caltagirone, MD

    Children's Hospital Colorado and University of Colorado Denver

    PRINCIPAL INVESTIGATOR

  • Kathleen Adelgais, MD, MPH

    Children's Hospital Colorado and University of Colorado Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 27, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

June 21, 2019

Results First Posted

June 21, 2019

Record last verified: 2019-06

Locations

US(1)