Pain, Needle Phobia
Conditions
Keywords
EMLA, venipuncture, children, Synera patch, pediatric, Lidocaine/prilocaine
Brief summary
This study compares the efficacy of the Synera patch with Eutectic Mixture of Local Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.
Detailed description
Venipunctures are common and necessary components of pediatric health care. Unfortunately, many children have needle phobia and even a simple procedure, such as a venipuncture, can cause significant stress and anxiety to the patient and the parents involved. Studies have shown that needles are the worst part of hospital/healthcare related visits for children. The Synera patch uses a controlled heating system to transcutaneously deliver a lidocaine/tetracaine mixture for analgesic effect. No published studies compare the efficacy of the Synera patch with other topical anesthetics in children. The objective of this study is to compare the efficacy of the Synera patch applied for 20 minutes with the efficacy of EMLA Cream applied for 60 minutes in reducing pain associated with venipunctures in children. Patients, 4-12 years old children requiring venipunctures in clinics, were randomized to receive Synera for 20 minutes or EMLA for 60 minutes. A blinded observer recorded pain scores using a numerical rating scale (NRS). Child and parent assessed pain with the Wong-Baker FACES Scale and the NRS, respectively. The primary outcome was the number of subjects reporting no pain. Secondary outcomes were parent and observer measures of the child's pain and the presence of skin reactions.
Interventions
DRUGEMLA Cream
60 minutes x1
COMBINATION_PRODUCTSynera Patch
20 minutes x1
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children in outpatient clinics requiring venipuncture for medical care * Ages 4-12 years old * The ability to demonstrate proper understanding of the Wong-Baker FACES Pain Ranking Scale * Parents of enrolled children need to be present during the procedure and be willing to rate their child's pain
Exclusion criteria
* Damaged or inflamed skin at the designated application site * Known sensitivity to components of Synera or EMLA (lidocaine, tetracaine, or local anesthetics of the amide or ester type, Para Aminobenzoic (PABA) derivatives) * Contraindications to SYnera or EMLA use (Severe hepatic disease, history of drug-induced methemoglobinemia, taking Class 1 antiarrhythmics) * Use of analgesics during the past 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | immediately after completion of venipuncture | Participants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, no pain, to 5, the most pain you can have. The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Rating of Child's Pain Using a 6-point NRS | immediately after venipuncture is completed | The Numerical Rating Scale (NRS) is a 6-point rating scale where 0= no pain and 5 = worst pain. Parents reported their own subjective evaluation of participants pain level. Each participant had only one parental assessment. Total number of parental assessment for each pain level on the 6-point NRS is reported as total number of participants experiencing that pain level. |
| Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | before venipuncture | The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at tourniquet placement. Total number of participants subjectively evaluated as experiencing each pain level is reported. |
| Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | during needle insertion | The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at needle insertion. Total number of participants subjectively evaluated as experiencing each pain level is reported. |
| Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | 5 minutes post venipuncture | The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain participants were experiencing 5 minutes after the venipuncture was completed. Total number of participants subjectively evaluated as experiencing each pain level is reported. |
Countries
United States
Participant flow
Recruitment details
Children, ages 4 - 12 , who had outpatient clinic visits between June 2007 and August 2008 at an urban, tertiary care hospital and required venipunctures for medical care were recruited for this study.
Participants by arm
| Arm | Count |
|---|---|
| EMLA Cream Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.
EMLA Cream: 60 minutes x1 | 50 |
| Synera Patch Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Synera Patch: 20 minutes x1 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | EMLA Cream | Synera Patch |
|---|---|---|---|
| Age, Continuous | 8.8 Years STANDARD_DEVIATION 2.5 | 8.7 Years STANDARD_DEVIATION 2.5 | 8.9 Years STANDARD_DEVIATION 2.5 |
| Number of participants with history of topical anesthetics use | 8 Participants | 4 Participants | 4 Participants |
| Number of Participants with Prior Venipunctures Less than10 venipunctures | 56 Participants | 29 Participants | 27 Participants |
| Number of Participants with Prior Venipunctures More than 10 venipunctures | 44 Participants | 21 Participants | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 10 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 62 Participants | 31 Participants | 31 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 11 Participants | 7 Participants | 4 Participants |
| Region of Enrollment United States | 100 Participants | 50 Participants | 50 Participants |
| Sex: Female, Male Female | 60 Participants | 29 Participants | 31 Participants |
| Sex: Female, Male Male | 40 Participants | 21 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 27 / 50 | 10 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
Participants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, no pain, to 5, the most pain you can have. The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5.
Time frame: immediately after completion of venipuncture
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EMLA Cream | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 0 (No pain) | 42 Participants |
| EMLA Cream | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 1 | 6 Participants |
| EMLA Cream | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 2 | 2 Participants |
| EMLA Cream | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 3 | 0 Participants |
| EMLA Cream | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 4 | 0 Participants |
| EMLA Cream | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 5 | 0 Participants |
| Synera Patch | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 4 | 0 Participants |
| Synera Patch | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 0 (No pain) | 38 Participants |
| Synera Patch | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 3 | 1 Participants |
| Synera Patch | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 1 | 8 Participants |
| Synera Patch | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 5 | 0 Participants |
| Synera Patch | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Participants with FACES Score = 2 | 3 Participants |
Secondary
Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at tourniquet placement. Total number of participants subjectively evaluated as experiencing each pain level is reported.
Time frame: before venipuncture
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EMLA Cream | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 0 (No pain) | 41 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 1 | 6 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 2 | 2 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 3 | 1 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 4 | 0 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 5 | 0 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 4 | 1 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 0 (No pain) | 37 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 3 | 1 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 1 | 6 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 5 | 0 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | Participants evaluated at NRS = 2 | 5 Participants |
Secondary
Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain participants were experiencing 5 minutes after the venipuncture was completed. Total number of participants subjectively evaluated as experiencing each pain level is reported.
Time frame: 5 minutes post venipuncture
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 3 | 1 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 2 | 1 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 4 | 0 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 1 | 3 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 5 | 0 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 0 (No pain) | 45 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 5 | 0 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 0 (No pain) | 45 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 2 | 1 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 3 | 0 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 4 | 0 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | Participants evaluated at NRS = 1 | 4 Participants |
Secondary
Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at needle insertion. Total number of participants subjectively evaluated as experiencing each pain level is reported.
Time frame: during needle insertion
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 0 (No pain) | 32 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 1 | 14 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 2 | 2 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 3 | 2 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 4 | 0 Participants |
| EMLA Cream | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 5 | 0 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 4 | 2 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 0 (No pain) | 25 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 3 | 2 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 1 | 12 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 5 | 0 Participants |
| Synera Patch | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | Participants evaluated at NRS = 2 | 9 Participants |
Secondary
Parent Rating of Child's Pain Using a 6-point NRS
The Numerical Rating Scale (NRS) is a 6-point rating scale where 0= no pain and 5 = worst pain. Parents reported their own subjective evaluation of participants pain level. Each participant had only one parental assessment. Total number of parental assessment for each pain level on the 6-point NRS is reported as total number of participants experiencing that pain level.
Time frame: immediately after venipuncture is completed
Population: Number of parent assessment for each pain level on the 6-point NRS. Each participant had only one parental assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EMLA Cream | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=0 (no pain) | 42 Participants |
| EMLA Cream | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=1 | 6 Participants |
| EMLA Cream | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=2 | 1 Participants |
| EMLA Cream | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=3 | 1 Participants |
| EMLA Cream | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=4 | 0 Participants |
| EMLA Cream | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=5 | 0 Participants |
| Synera Patch | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=4 | 0 Participants |
| Synera Patch | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=0 (no pain) | 41 Participants |
| Synera Patch | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=3 | 2 Participants |
| Synera Patch | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=1 | 5 Participants |
| Synera Patch | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=5 | 1 Participants |
| Synera Patch | Parent Rating of Child's Pain Using a 6-point NRS | number of participants with NRS=2 | 1 Participants |