Anxiety, Pain
Conditions
Keywords
pediatric patients, pain, anxiety, topical anesthetic, randomized control trial
Brief summary
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.
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).
Interventions
DRUG4% lidocaine topical anesthetic cream
A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture
DRUGPlacebo cream
A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture
Sponsors
Jenny Boucher, PharmD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain From Venipuncture | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety of Venipuncture | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| ControI Group Receiving Placebo Cream Before Venipuncture Experimential group receiving medicated topical cream prior to venipuncture | 57 |
| Investigational Group Investigational group receiving blinded 4% lidocaine cream | 57 |
| Total | 114 |
Baseline characteristics
| Characteristic | Investigational Group | ControI Group Receiving Placebo Cream Before Venipuncture | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 57 Participants | 57 Participants | 114 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 11.6 years STANDARD_DEVIATION 3.7 | 11.6 years STANDARD_DEVIATION 3.7 | 11.6 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment United States | 57 participants | 57 participants | 114 participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 |
Outcome results
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.
Time frame: Pain was measured immediately after venipuncture.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ControI Group Receiving Placebo Cream | Pain From Venipuncture | 2.2 scores on a scale | Standard Deviation 1.4 |
| Investigational Group | Pain From Venipuncture | 2.1 scores on a scale | Standard Deviation 1.6 |
Comparison: P-value determined from linear regression models that include age, gender, number of needle sticks in previous 2 years and nurse reported difficulty in performing venipuncture.p-value: 0.71Chi-squared
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.
Time frame: During venipuncture
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ControI Group Receiving Placebo Cream | Anxiety of Venipuncture | 43.1 scores on a scale | Standard Deviation 36.5 |
| Investigational Group | Anxiety of Venipuncture | 40.5 scores on a scale | Standard Deviation 36.4 |