Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4% lidocaine topical anesthetic cream | Active Comparator | This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick. |
|
| Placebo | Placebo Comparator | This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% lidocaine topical anesthetic cream | Drug | A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain From 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. | Pain was measured immediately after venipuncture. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety of 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jenny Boucher, PharmD | Lehigh Valley Hospital | Principal Investigator |
| Scott Brenner, MD | Lehigh Valley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10353976 | Background | Koh JL, Fanurik D, Stoner PD, Schmitz ML, VonLanthen M. Efficacy of parental application of eutectic mixture of local anesthetics for intravenous insertion. Pediatrics. 1999 Jun;103(6):e79. doi: 10.1542/peds.103.6.e79. | |
| 8867250 | Background | Lander J, Hodgins M, Nazarali S, McTavish J, Ouellette J, Friesen E. Determinants of success and failure of EMLA. Pain. 1996 Jan;64(1):89-97. doi: 10.1016/0304-3959(95)00100-X. |
Not provided
Not provided
A convenience sample was utilized due to the availability of the research study coordinator who completed the enrollment from 7 am to 5 pm Monday through Friday. One participant was excluded from analysis due to ineligibility.
The study was conducted at one site of a multi-site, academic, community emergency department. Children between the ages of five and 18 years of age were considered for enrollment into the study if they were seen in the emergency department (ED) and a physician order was placed for intravenous cannulation or labs to be drawn by venipuncture.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ControI Group Receiving Placebo Cream | Control group receiving blinded placebo cream under occlusive dressing prior to venipuncture |
| FG001 | Investigational Group Receiving 4% Lidocaine | Investigational group receiving blinded 4% lidocaine cream under occlusive dressing for 15 mins prior to venipuncture |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ControI Group Receiving Placebo Cream Before Venipuncture | Experimential group receiving medicated topical cream prior to venipuncture |
| BG001 | Investigational Group | Investigational group receiving blinded 4% lidocaine cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Anxiety of 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. | We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis. | Posted | Mean | Standard Deviation | scores on a scale | During venipuncture |
|
The participants were followed for the duration of the study period, an average of three hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ControI Group Receiving Placebo Cream | Control group receiving placebo topical cream prior to venipuncture |
Not provided
Not provided
Convenience sample at one hospital site during dayshift hours Monday through Friday. Variable ages may increase the variance among pain measurements. Analyzed IV cannulation and lab draw together. We did not conduct interrater reliability testing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jenny Boucher | Lehigh Valley Health Network | 610-402-8844 | jenny.boucher@LVH.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo cream | Drug | A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture |
|
| During venipuncture |
| 12042548 | Background | Eichenfield LF, Funk A, Fallon-Friedlander S, Cunningham BB. A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children. Pediatrics. 2002 Jun;109(6):1093-9. doi: 10.1542/peds.109.6.1093. |
| 15520120 | Background | Zempsky WT, Cravero JP; American Academy of Pediatrics Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine. Relief of pain and anxiety in pediatric patients in emergency medical systems. Pediatrics. 2004 Nov;114(5):1348-56. doi: 10.1542/peds.2004-1752. |
| 1517650 | Background | Lander J, Fowler-Kerry S, Oberle S. Children's venipuncture pain: influence of technical factors. J Pain Symptom Manage. 1992 Aug;7(6):343-9. doi: 10.1016/0885-3924(92)90087-x. |
| 19528768 | Background | Barnett P. Alternatives to sedation for painful procedures. Pediatr Emerg Care. 2009 Jun;25(6):415-9; quiz 420-2. doi: 10.1097/PEC.0b013e3181a93ff3. |
| 15601345 | Background | Koh JL, Harrison D, Myers R, Dembinski R, Turner H, McGraw T. A randomized, double-blind comparison study of EMLA and ELA-Max for topical anesthesia in children undergoing intravenous insertion. Paediatr Anaesth. 2004 Dec;14(12):977-82. doi: 10.1111/j.1460-9592.2004.01381.x. |
| 19690240 | Background | Bringuier S, Dadure C, Raux O, Dubois A, Picot MC, Capdevila X. The perioperative validity of the visual analog anxiety scale in children: a discriminant and useful instrument in routine clinical practice to optimize postoperative pain management. Anesth Analg. 2009 Sep;109(3):737-44. doi: 10.1213/ane.0b013e3181af00e4. |
| 20003121 | Background | Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9. |
| 2678015 | Background | Gift AG. Visual analogue scales: measurement of subjective phenomena. Nurs Res. 1989 Sep-Oct;38(5):286-8. No abstract available. |
| 20921070 | Background | 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. |
| 2197679 | Background | Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405. |
| 18520909 | Background | Kaweski S; Plastic Surgery Educational Foundation Technology Assessment Committee. Topical anesthetic creams. Plast Reconstr Surg. 2008 Jun;121(6):2161-2165. doi: 10.1097/PRS.0b013e318170a7a4. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Investigational Group | Investigational group receiving 4% lidocaine cream prior to venipuncture |
|
|
| Primary | Pain From 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. | We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis. | Posted | Mean | Standard Deviation | scores on a scale | Pain was measured immediately after venipuncture. |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Investigational Group | Investigational group receiving 4% lidocaine cream prior to venipuncture | 0 | 57 | 0 | 57 |
Not provided
Not provided
Not provided