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| Name | Class |
|---|---|
| Kosair Charities, Inc. | OTHER |
| University of Kentucky | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk | Experimental | Milk bottle administration |
|
| Water | Experimental | Water bottle administration |
|
| Sucrose | Experimental | Sucrose bottle administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk bottle administration | Other | Patients are given a bottle of milk during the casting process. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd M Milbrandt, MD | Shriners Hospital for Children, Mayo Clinic | Principal Investigator |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | 33 Participants were randomized to one of 18 sequences of milk, water, or formula for an average of 6 casting visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis included 43 casts receiving sucrose, 37 casts receiving milk or formula, and 42 casts receiving water
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Because this was a crossover design, multiple casts were assessed for each participant | Posted | Mean | Standard Deviation | units on a scale | Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting. | casts | casts |
up to four weeks after study participation
Patients were monitored for gastrointestinal, systemic, or allergic reactions during routine clinical follow-up visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sucrose | Bottle Administration: 2 oz sucrose solution 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment | At 7 days post-treatment, subject's guardian reported that the subject was gassy, spitt up, didn't eat well, and diarrhea with chapped bottom following treatment but that the problem had resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Davis | Shriners Hospital for Children | 859-268-5705 | rfdavis@shrinenet.org |
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| ID | Term |
|---|---|
| D003025 | Clubfoot |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| Water bottle administration | Other | Patients are given a bottle of water during the casting process. |
|
| Sucrose bottle administration | Other | Patients are given a bottle of sucrose during the casting process. |
|
| 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. | Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Milk | Bottle Administration: 2 oz milk or 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. |
| OG001 | Water | Bottle Administration: 2 oz water 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. |
| OG002 | Sucrose | Bottle Administration: 2 oz sucrose solution 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. |
|
|
| 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. | Because this was a crossover design, multiple casts were assessed for each participant | Posted | Mean | Standard Deviation | bpm | Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting. | casts | casts |
|
|
|
| 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. | Because this was a crossover design, multiple casts were assessed for each participant | Posted | Mean | Standard Deviation | percentage of SpO2 | Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting | casts | casts |
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Milk or Formula | Bottle Administration: 2 oz milk or 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. | 0 | 26 | 0 | 26 |
| EG002 | Water | Bottle Administration: 2 oz water 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. | 0 | 26 | 0 | 26 |
|
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| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
|
| post casting |
|
|
| post casting |
|