Clinical trial NCT02395185: A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants
Official title: A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clubfoot
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
Collaborators: name: Kosair Charities, Inc.
name: University of Kentucky
First posted: 2015-03-20
Enrollment: 33
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: NIPS (Neonatal Infant Pain Scale)
timeFrame: Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.
Secondary outcomes:
measure: Heart Rate
timeFrame: Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.
measure: Oxygen Saturation
timeFrame: Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting
Other outcomes:
Locations:
Study officials:
affiliation: Shriners Hospital for Children, Mayo Clinic
name: Todd M Milbrandt, MD
role: PRINCIPAL_INVESTIGATOR
References: