Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
|ClinicalTrials.gov Identifier: NCT00676364|
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : September 25, 2012
Last Update Posted : September 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pain Anxiety||Drug: 4% lidocaine topical anesthetic cream Drug: Placebo cream||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
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
- Pain From Venipuncture [ Time Frame: Pain was measured immediately after venipuncture. ]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.
- Anxiety of Venipuncture [ Time Frame: During venipuncture ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676364
|United States, Pennsylvania|
|Lehigh Valley Hospital|
|Allentown, Pennsylvania, United States, 18103|
|Principal Investigator:||Jenny Boucher, PharmD||Lehigh Valley Hospital|
|Principal Investigator:||Scott Brenner, MD||Lehigh Valley Hospital|