Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
This study has been completed.
Sponsor:
Jenny Boucher, PharmD
Information provided by (Responsible Party):
Jenny Boucher, PharmD, Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT00676364
First received: May 9, 2008
Last updated: August 24, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to evaluate the amount of anxiety and pain felt by children during procedures that require a needle stick after using a topical anesthetic or placebo cream.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Anxiety |
Drug: 4% lidocaine topical anesthetic cream Drug: Placebo cream |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Placebo-Controlled Trial to Evaluate Pain and Anxiety During Venipuncture in Pediatric Patients With or Without Pre-treatment by a Topical Anesthetic |
Resource links provided by NLM:
Further study details as provided by Lehigh Valley Hospital:
Primary Outcome Measures:
- Pain From Venipuncture [ Time Frame: Pain was measured immediately after venipuncture. ] [ Designated as safety issue: No ]Pain was measured immediately after venipuncture by the participant using the six-point FACES scale. "FACES" in not an acronym, but rather a description of a pain scale that uses pictures of faces in various states of pain. The FACES pain scale is a common scale used to measure pain with scores on a scale. The scale we used had six points from zero (0) to five (5) indicating different levels of pain. Lower scores indicate lower levels of pain, and higher scores indicate higher levels of pain.
Secondary Outcome Measures:
- Anxiety of Venipuncture [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]Participant anxiety was measured by the study participant and the objective observer before (anticipatory), during (venipuncture) and after (recovery) venipuncture using a validated visual analog scale (VAS). The VAS is a validated scale that is used to detect small changes in many types of observations. The scale ranges from 0-100 scores on a scale, and here the higher scores indicate higher anxiety levels. Only the participant's mean venipuncture (during venipuncture) anxiety scores are presented in outcome measure results here.
| Enrollment: | 114 |
| Study Start Date: | March 2003 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 4% lidocaine topical anesthetic cream
This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick.
|
Drug: 4% lidocaine topical anesthetic cream
A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture
Other Name: 4% liposomal lidocaine (Brand name = LMX4)
|
|
Placebo Comparator: Placebo
This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick.
|
Drug: Placebo cream
A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture
Other Name: Placebo cream
|
Detailed Description:
Pediatric patients frequently receive eutectic mixture of local anesthetics (EMLA) or other anesthetic medications prior to venipuncture. However, the time for the anesthetic to take affect is approximately 60 minutes. Another anesthetic medication besides EMLA is lidocaine 4% topical anesthetic cream (LMX4), which has a shorter acting time (30 minutes) compared to the EMLA, making it a more desirable medication when urgent labs are required. This medication is being evaluated to assess the anxiety and pain associated with venipuncture in 15 minutes versus the approved 30 minutes of pediatric patients treated as an inpatient or outpatient in the local Emergency Department, compared to standard care (no prior treatment).
Eligibility| Ages Eligible for Study: | 5 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- children ages 5-18 years of age
- treated as an inpatient or outpatient at Lehigh Valley Hospital within the past 24 hours
- venipuncture order, and that order is their initial venipuncture order (required within 30 mins)
Exclusion Criteria:
- known allergy to EMLA, LMX4 or any of their ingredients
- known sensitivities to local anesthetics of the amide type, lidocaine or prilocaine
- G6PD deficiency
- methemoglobinemia or concomitant administration of methemoglobin-inducing agent
- brain injured or disoriented (Glasgow Coma Scale <15)
- cognitively impaired (Mini Mental Status Exam <28)
- active skin conditions at venipuncture site including frequent rashes, eczema or unexplained bruising
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676364
Locations
| United States, Pennsylvania | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18103 | |
Sponsors and Collaborators
Jenny Boucher, PharmD
Investigators
| Principal Investigator: | Jenny Boucher, PharmD | Lehigh Valley Hospital |
| Principal Investigator: | Scott Brenner, MD | Lehigh Valley Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Jenny Boucher, PharmD, Investigator, Lehigh Valley Hospital |
| ClinicalTrials.gov Identifier: | NCT00676364 History of Changes |
| Other Study ID Numbers: | 1-20030313 |
| Study First Received: | May 9, 2008 |
| Results First Received: | May 1, 2012 |
| Last Updated: | August 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Lehigh Valley Hospital:
|
pediatric patients pain anxiety topical anesthetic randomized control trial |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Anesthetics Lidocaine Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013