Pain
Conditions
Keywords
Infant,newborn, Topical anesthesia, Intramuscular injection
Brief summary
This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in decreasing the pain from intramuscular injection in term neonates.
Detailed description
This randomized controlled trial will assess the efficacy of topical amethocaine gel (Ametop) compared with placebo (Eucerin plus) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Neonatal pain response between groups will be assessed using the Neonatal Facial Action Coding System (NFCS) which is currently the gold standard for infant pain assessment, latency to first cry and cry duration. Parents' (father) perception of infant's pain will be assessed using a visual analogue scale (VAS) when possible. Neonates will be randomized to receive either amethocaine gel or identical appearing placebo administered locally at the injection site (the upper part of the neonate's thigh) using a pre-prepared syringe 30 minutes prior to the administration of vitamin K. The gel or placebo will be covered using a Saran wrap. Each neonate will be videotaped during the procedure. Parents (father) will be present during the procedure (observing) so that they (he) can assess their neonate's pain response using VAS.
Interventions
DRUGAmethocaine gel 4%
1 g, single application
DRUGEucerin plus
1g, single application
Sponsors
Striving for Excellence Fund, Mount Sinai Hospital
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Hours to 72 Hours
Healthy volunteers
No
Inclusion criteria
1. Term neonates \> 37 weeks and 2. Birth weight \> 2500 grams (appropriate for gestational age - AGA) -
Exclusion criteria
1. Neonates with major congenital anomalies 2. Neonates with known neurological abnormalities (antenatally diagnosed) 3. Neonates who require admission to the neonatal intensive care unit at birth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores Assessed by Neonatal Facial Action | For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds. | The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted \< 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | During the entire procedure | Parents and nurses were asked to assess the infant's pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0=no pain on the left side and 10=worst possible pain on the right side. Parents and nurses were trained to use the VAS prior to the IM injection. |
Countries
Canada
Participant flow
Recruitment details
The study was conducted between July 2003 and December 2004 in the Labour and Delivery Unit of Mount Sinai Hospital.
Participants by arm
| Arm | Count |
|---|---|
| Amethocaine Gel 4% Group 1 g of topical amethocaine gel 4%. | 55 |
| Placebo Group 1 g Eucerin plus was used as a placebo. | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | Placebo Group | Amethocaine Gel 4% Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 55 Participants | 55 Participants | 110 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 | 39.2 years STANDARD_DEVIATION 1 | 39.3 years STANDARD_DEVIATION 1.1 | 39.25 years STANDARD_DEVIATION 1.05 |
| Region of Enrollment Canada | 55 participants | 55 participants | 110 participants |
| Sex: Female, Male Female | 32 Participants | 25 Participants | 57 Participants |
| Sex: Female, Male Male | 23 Participants | 30 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 54 | 4 / 53 |
| serious Total, serious adverse events | 0 / 54 | 0 / 53 |
Outcome results
Primary
Pain Scores Assessed by Neonatal Facial Action
The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted \< 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain.
Time frame: For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds.
Population: Intention to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 g Amethocaine Gel 4% | Pain Scores Assessed by Neonatal Facial Action | Baseline | 14 Percentage of time | Standard Deviation 26 |
| 1 g Amethocaine Gel 4% | Pain Scores Assessed by Neonatal Facial Action | Cleaning | 30 Percentage of time | Standard Deviation 39 |
| 1 g Amethocaine Gel 4% | Pain Scores Assessed by Neonatal Facial Action | Injection | 70 Percentage of time | Standard Deviation 32 |
| 1 g Amethocaine Gel 4% | Pain Scores Assessed by Neonatal Facial Action | Recovery | 79 Percentage of time | Standard Deviation 24 |
| Placebo Group | Pain Scores Assessed by Neonatal Facial Action | Recovery | 76 Percentage of time | Standard Deviation 28 |
| Placebo Group | Pain Scores Assessed by Neonatal Facial Action | Baseline | 18 Percentage of time | Standard Deviation 28 |
| Placebo Group | Pain Scores Assessed by Neonatal Facial Action | Injection | 75 Percentage of time | Standard Deviation 34 |
| Placebo Group | Pain Scores Assessed by Neonatal Facial Action | Cleaning | 44 Percentage of time | Standard Deviation 42 |
Comparison: We hypothesized that topical amethocaine gel 4% would reduce the pain from IM injection. The sample size was based on the pain scores obtained from a previous study that compared pain response during IM injection. To achieve a clinically significant reduction in pain scores by 20% between groups with 80% power and an alpha value of \< 0.05, we estimated sample size of 49 neonates in each group. A total of 110 neonates were enrolled to account for possible dropouts and missing data.p-value: <0.05t-test, 2 sided
Secondary
Visual Analogue Scale
Parents and nurses were asked to assess the infant's pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0=no pain on the left side and 10=worst possible pain on the right side. Parents and nurses were trained to use the VAS prior to the IM injection.
Time frame: During the entire procedure
Population: Intention to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 g Amethocaine Gel 4% | Visual Analogue Scale | Parents VAS rating | 4.6 Cms | Standard Deviation 2.3 |
| 1 g Amethocaine Gel 4% | Visual Analogue Scale | Nurses VAS rating | 5.0 Cms | Standard Deviation 2.1 |
| Placebo Group | Visual Analogue Scale | Parents VAS rating | 4.6 Cms | Standard Deviation 2.4 |
| Placebo Group | Visual Analogue Scale | Nurses VAS rating | 4.9 Cms | Standard Deviation 2.3 |
Comparison: We hypothesized that parents and nurses will report lower pain scores as assessed by visual analogue scale in topical amethocaine gel 4% compared to placebo group. This was a secondary outcome and no power calculation was performed.p-value: <0.05t-test, 2 sided