Children, Pain
Conditions
Keywords
Children, Pain, Vaccination, Emla, Pneumococcal, Pain scale
Brief summary
The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief or no pain relief in connection to the first pneumococcal vaccination at the age of three months in Child health care. Primary objective 1.Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at the age of three months to lower pain scores in the use of five items; Face, Legs, Activity, Cry, Consolability (FLACC scale) as a pain measurement instrument?
Detailed description
The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief or no pain relief in connection to the first pneumococcal vaccination at the age of three months in Child health care. Primary objective 1. Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at the age of three months to lower pain scores in the use of FLACC scale as a pain measurement instrument? Secondary objectives 2. Leads Emla cream as pain relief in connection with pneumococcal vaccination to any difference in the child's heart rate response and saturation? 3. Leads Emla cream as pain relief that it takes longer before the baby starts crying and does the child cry for a shorter time in connection with vaccination? Method: The study is randomised and singleblind. The study involves 72 children who are 3 months old. 36 children will receive Emla-cream and 36 children will receive placebo-cream. This study will lead to new knowledge about Emla cream and pneumococcal vaccination. The study will give new knowledge how painful pneumococcal vaccination is for the children. If the study shows that Emla cream don´t give enough pain relief during pneumococcal vaccination more studies should be done with other pain relief.
Interventions
DRUGEmla-cream
Topical anaesthetic
DRUGMiniderm cream
Topical
Sponsors
Beatrice Olsson Duse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 4 Months
Healthy volunteers
No
Inclusion criteria
* Healthy children, born vaginally or by cesarean section after 37 weeks of gestation, who were not admitted to the neonatal unit. Children should only have been with the newborn screening performed routinely at the hospital.
Exclusion criteria
* Baby delivered by vacuum extraction or forceps. Children born before gestational week 37. Children in neonatal care and subjected to other testing than newborn screening. Shoulder dystocia. Children susceptible to methaemoglobinaemia in glucose 6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia. Children with atopic dermatitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale). | Before vaccination and after vaccination, up to three minutes. | The effect of Emla cream on pain perception during pneumococcal vaccination was measured by FLACC scale that includes five items; Face, Legs, Activity, Cry, Consolability. FLACC scale i a qualitative behavioural scale used for pain assesment and has been validated for use in infants aged 2 months to 7 years. Each item (Face, Legs, Activity, Cry and Consolability) can give 0,1 or 2 points according to the description included in the FLACC scale. The total summarised pain score can range between 0-10 points. A higher pain-score indicate more pain, which means a worse outcome. FLACC scale was measured before and after vaccination and compared between the groups (Emla-cream vs Miniderm cream). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception Measured With Latency Time to Cry and Total Crying Time. | Before vaccination and after vaccination, up to three minutes. | Latency time to cry (scored in seconds): * how long does it takes until the baby starts to cry after vaccination was performed (the longer it takes until the baby starts to cry indicate less pain, a better outcome). Min- or maximum values is not applicable. Total crying time (scored in seconds): * how long time is the baby crying after vaccination was performed (the longer time the baby is crying indicate more pain, a worse outcome). Min- or maximum values is not applicable. |
| Heart Rate (Beats Per Minute) Before and After Vaccination | Before vaccination and after vaccination, up to three minutes | Heart rate before and after vaccination (beats per minute), higher values indicate more pain, a worse outcome. Min and max values are not applicable. |
| Saturation Before and After Vaccination. | Before vaccination and after vaccination, up to three minutes | Oxygen saturation before and after vaccination (0-100%), a lower value indicate more pain, a worse outcome |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Emla-cream Dose: 1 g Emla-cream, 1 hour.
Emla-cream: Topical anaesthetic | 36 |
| Miniderm Cream Dose: 1 g Miniderm-cream, 1 hour.
Miniderm cream: Topical | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | Emla-cream | Miniderm Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 36 Participants | 72 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 23 Participants | 17 Participants | 40 Participants |
| Sex: Female, Male Male | 13 Participants | 19 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale).
The effect of Emla cream on pain perception during pneumococcal vaccination was measured by FLACC scale that includes five items; Face, Legs, Activity, Cry, Consolability. FLACC scale i a qualitative behavioural scale used for pain assesment and has been validated for use in infants aged 2 months to 7 years. Each item (Face, Legs, Activity, Cry and Consolability) can give 0,1 or 2 points according to the description included in the FLACC scale. The total summarised pain score can range between 0-10 points. A higher pain-score indicate more pain, which means a worse outcome. FLACC scale was measured before and after vaccination and compared between the groups (Emla-cream vs Miniderm cream).
Time frame: Before vaccination and after vaccination, up to three minutes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Emla-cream | Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale). | FLACC score before vaccination | 0 score on a scale |
| Emla-cream | Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale). | FLACC score after vaccination | 7 score on a scale |
| Miniderm Cream | Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale). | FLACC score before vaccination | 0 score on a scale |
| Miniderm Cream | Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale). | FLACC score after vaccination | 9 score on a scale |
Secondary
Heart Rate (Beats Per Minute) Before and After Vaccination
Heart rate before and after vaccination (beats per minute), higher values indicate more pain, a worse outcome. Min and max values are not applicable.
Time frame: Before vaccination and after vaccination, up to three minutes
Population: We analysed the babies heart rate (beats per minute) before and after vaccination.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emla-cream | Heart Rate (Beats Per Minute) Before and After Vaccination | Beats per minute before vaccination | 148.31 beats per minute | Standard Deviation 17.33 |
| Emla-cream | Heart Rate (Beats Per Minute) Before and After Vaccination | Beats per minute after vaccination | 159.59 beats per minute | Standard Deviation 15.53 |
| Miniderm Cream | Heart Rate (Beats Per Minute) Before and After Vaccination | Beats per minute before vaccination | 147.93 beats per minute | Standard Deviation 17.95 |
| Miniderm Cream | Heart Rate (Beats Per Minute) Before and After Vaccination | Beats per minute after vaccination | 160.46 beats per minute | Standard Deviation 17.36 |
Secondary
Pain Perception Measured With Latency Time to Cry and Total Crying Time.
Latency time to cry (scored in seconds): * how long does it takes until the baby starts to cry after vaccination was performed (the longer it takes until the baby starts to cry indicate less pain, a better outcome). Min- or maximum values is not applicable. Total crying time (scored in seconds): * how long time is the baby crying after vaccination was performed (the longer time the baby is crying indicate more pain, a worse outcome). Min- or maximum values is not applicable.
Time frame: Before vaccination and after vaccination, up to three minutes.
Population: We analysed for how long time it takes until the baby starts to cry and for how long time the baby is crying.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emla-cream | Pain Perception Measured With Latency Time to Cry and Total Crying Time. | Latency time to cry (seconds) | 2.77 Time in seconds | Standard Deviation 0.8 |
| Emla-cream | Pain Perception Measured With Latency Time to Cry and Total Crying Time. | Total crying time (seconds) | 78.74 Time in seconds | Standard Deviation 45.866 |
| Miniderm Cream | Pain Perception Measured With Latency Time to Cry and Total Crying Time. | Latency time to cry (seconds) | 2.05 Time in seconds | Standard Deviation 0.978 |
| Miniderm Cream | Pain Perception Measured With Latency Time to Cry and Total Crying Time. | Total crying time (seconds) | 100.44 Time in seconds | Standard Deviation 73.307 |
Secondary
Saturation Before and After Vaccination.
Oxygen saturation before and after vaccination (0-100%), a lower value indicate more pain, a worse outcome
Time frame: Before vaccination and after vaccination, up to three minutes
Population: We analysed the babies oxygen saturation before and after vaccination.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emla-cream | Saturation Before and After Vaccination. | Before vaccination | 99.59 percentage of oxygen saturation | Standard Deviation 0.82 |
| Emla-cream | Saturation Before and After Vaccination. | After vaccination | 98.86 percentage of oxygen saturation | Standard Deviation 1.22 |
| Miniderm Cream | Saturation Before and After Vaccination. | Before vaccination | 99.78 percentage of oxygen saturation | Standard Deviation 0.43 |
| Miniderm Cream | Saturation Before and After Vaccination. | After vaccination | 98.76 percentage of oxygen saturation | Standard Deviation 2.06 |