Clubfoot
Conditions
Brief summary
While it has been shown that sucrose or milk ingestion decreases pain responses in heel sticks, no study up to this point has determined the best intervention for decreasing the pain response during casting for clubfoot deformity. The goal of this study is to investigate the effect of three different non-pharmacologic interventions (sucrose, milk, water) on pain response during clubfoot casting. This study will allow us to discern the best non-pharmacologic intervention for pain control during clubfoot casting and to provide a more pleasant, comfortable experience for patients and families.
Detailed description
Clubfoot deformity in newborns is common, occurring in 1-2/1000 births. Treatment of this deformity has shifted from surgical to non-surgical management. The non-surgical management includes utilizing the Ponseti technique of manipulation and casting, followed by Achilles tenotomy and brace application. The newborn undergoes, on average, 4-6 casts before the foot deformity is corrected. During this manipulation and casting, the infants can become fussy and irritable. This irritability is likely due to discomfort felt from the manipulative process and subsequent casting. Studies that have focused on decreasing the pain response to heel sticks for laboratory testing in the neonatal intensive care units used sucrose or milk ingestion and swaddling in newborns to decrease pain responses. Both sucrose and milk have been shown to decrease the pain response as measured by the Premature Infant Pain Profile (PIPP) or the Bernese Pain Scale for Neonates. In addition, other pain scales have been used in newborn babies including the CRIES, CHIPPS, NIPS, and COMFORT scales to evaluate the effectiveness of pain relieving interventions. These scales were used alongside objective physiologic measurements such as heart rate, heart rate variability (HRV), respiratory rate, and oxygen saturation. While it has been shown that sucrose or milk ingestion decreases pain responses in heel sticks, no study up to this point has determined the best intervention for decreasing the pain response during casting for clubfoot deformity. The goal of this study is to investigate the effect of three different non-pharmacologic interventions (sucrose, milk, water) on pain response during clubfoot casting, allowing us to discern the best non-pharmacologic intervention for pain control during clubfoot casting and to provide a more pleasant, comfortable experience for patients and families. A secondary objective is to investigate whether or not family environment or the level of anxiety felt by the parents impacts the pain felt by the infant during the casting process.
Interventions
OTHERMilk bottle administration
Patients are given a bottle of milk during the casting process.
OTHERWater bottle administration
Patients are given a bottle of water during the casting process.
OTHERSucrose bottle administration
Patients are given a bottle of sucrose during the casting process.
Sponsors
Kosair Charities, Inc.
University of Kentucky
Shriners Hospitals for Children
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Months
Healthy volunteers
No
Inclusion criteria
* idiopathic clubfoot deformity * undergoing clubfoot casting for correction
Exclusion criteria
* cannot use a bottle for feeding * on solid food * have had surgery * have been given an analgesic within three hours prior to data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIPS (Neonatal Infant Pain Scale) | Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting. | Each cast visit will be videotaped before, during, and after casting, and later reviewed for subjective evaluation of pain using NIPS (Neonatal Infant Pain Scale). The NIPS examines six behavioral groupings that contribute to a pain score ranging from 0 to 7: facial expression (relaxed muscles or grimace), cry (no cry, whimper, or vigorous cry), breathing patterns (relaxed, change in breathing), arms (relaxed/restrained, flexed/extended), legs (relaxed/restrained, flexed/extended), state of arousal (sleeping/awake, fussy). Scoring will take place by a trained study personnel blinded to the contents of the bottle. Scoring for all measures will be recorded at minute intervals. A pre casting score from the average of the first 3 minute scores prior to casting; a during casting score from the average of the scores at 1 minute intervals during casting; and a post casting score from the average of the 3 minute scores post casting. Scores are categorized as 0 no pain, to \>4 severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting. | Heart rate will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting. |
| Oxygen Saturation | Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting | Oxygen saturation will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting. |
Participant flow
Recruitment details
53 participants were assessed for eligability. 33 patient participants and their guardians were enrolled in the study from 3/13/13 to 9/17/14 at their initial clinical visit. A total of 131 casts were performed.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Bottle Administration: 2 oz of sucrose, water, or milk/formula given in a bottle during the casting process
Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 17.9 days STANDARD_DEVIATION 20.5 |
| Age, Customized <=18 years | 33 participants |
| Age, Customized >=65 years | 0 participants |
| Age, Customized Between 18 and 65 years | 0 participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 29 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 29 | 0 / 26 | 0 / 26 |
Outcome results
Primary
NIPS (Neonatal Infant Pain Scale)
Each cast visit will be videotaped before, during, and after casting, and later reviewed for subjective evaluation of pain using NIPS (Neonatal Infant Pain Scale). The NIPS examines six behavioral groupings that contribute to a pain score ranging from 0 to 7: facial expression (relaxed muscles or grimace), cry (no cry, whimper, or vigorous cry), breathing patterns (relaxed, change in breathing), arms (relaxed/restrained, flexed/extended), legs (relaxed/restrained, flexed/extended), state of arousal (sleeping/awake, fussy). Scoring will take place by a trained study personnel blinded to the contents of the bottle. Scoring for all measures will be recorded at minute intervals. A pre casting score from the average of the first 3 minute scores prior to casting; a during casting score from the average of the scores at 1 minute intervals during casting; and a post casting score from the average of the 3 minute scores post casting. Scores are categorized as 0 no pain, to \>4 severe pain.
Time frame: Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.
Population: Because this was a crossover design, multiple casts were assessed for each participant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk | NIPS (Neonatal Infant Pain Scale) | NIPS post casting | 2.11 units on a scale | Standard Deviation 2.37 |
| Milk | NIPS (Neonatal Infant Pain Scale) | NIPS casting | 0.91 units on a scale | Standard Deviation 1.26 |
| Milk | NIPS (Neonatal Infant Pain Scale) | NIPS pre casting | 2.28 units on a scale | Standard Deviation 2.38 |
| Water | NIPS (Neonatal Infant Pain Scale) | NIPS pre casting | 1.63 units on a scale | Standard Deviation 2.12 |
| Water | NIPS (Neonatal Infant Pain Scale) | NIPS casting | 2.22 units on a scale | Standard Deviation 2.01 |
| Water | NIPS (Neonatal Infant Pain Scale) | NIPS post casting | 1.49 units on a scale | Standard Deviation 2.29 |
| Sucrose | NIPS (Neonatal Infant Pain Scale) | NIPS pre casting | 1.84 units on a scale | Standard Deviation 2.18 |
| Sucrose | NIPS (Neonatal Infant Pain Scale) | NIPS post casting | 0.69 units on a scale | Standard Deviation 1.53 |
| Sucrose | NIPS (Neonatal Infant Pain Scale) | NIPS casting | 0.63 units on a scale | Standard Deviation 1.27 |
Secondary
Heart Rate
Heart rate will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.
Time frame: Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.
Population: Because this was a crossover design, multiple casts were assessed for each participant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk | Heart Rate | casting | 152.54 bpm | Standard Deviation 12.87 |
| Milk | Heart Rate | pre casting | 152.72 bpm | Standard Deviation 20.45 |
| Milk | Heart Rate | post casting | 147.2 bpm | Standard Deviation 12.05 |
| Water | Heart Rate | casting | 152.59 bpm | Standard Deviation 9.03 |
| Water | Heart Rate | pre casting | 145.69 bpm | Standard Deviation 17.12 |
| Water | Heart Rate | post casting | 143.89 bpm | Standard Deviation 13.06 |
| Sucrose | Heart Rate | pre casting | 155.9 bpm | Standard Deviation 15.71 |
| Sucrose | Heart Rate | post casting | 149.78 bpm | Standard Deviation 12.99 |
| Sucrose | Heart Rate | casting | 154.33 bpm | Standard Deviation 24.55 |
Secondary
Oxygen Saturation
Oxygen saturation will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.
Time frame: Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting
Population: Because this was a crossover design, multiple casts were assessed for each participant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Milk | Oxygen Saturation | post casting | 98.07 percentage of SpO2 | Standard Deviation 2.07 |
| Milk | Oxygen Saturation | casting | 97.38 percentage of SpO2 | Standard Deviation 1.26 |
| Milk | Oxygen Saturation | pre casting | 98 percentage of SpO2 | Standard Deviation 1.57 |
| Water | Oxygen Saturation | post casting | 97.85 percentage of SpO2 | Standard Deviation 2.34 |
| Water | Oxygen Saturation | pre casting | 97.52 percentage of SpO2 | Standard Deviation 2.26 |
| Water | Oxygen Saturation | casting | 97.56 percentage of SpO2 | Standard Deviation 3.23 |
| Sucrose | Oxygen Saturation | casting | 94.32 percentage of SpO2 | Standard Deviation 12.43 |
| Sucrose | Oxygen Saturation | pre casting | 98.33 percentage of SpO2 | Standard Deviation 1.63 |
| Sucrose | Oxygen Saturation | post casting | 98.18 percentage of SpO2 | Standard Deviation 1.62 |