A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants
Condition: Clubfoot
MeSH terms: Clubfoot; Talipes; Equinus Deformity
Study type: Interventional

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.
    

Intervention name(s): Milk bottle administration; Water bottle administration; Sucrose bottle administration
Intervention type(s): Other; Other; Other
Intervention description(s): Patients are given a bottle of milk during the casting process.; Patients are given a bottle of water during the casting process.; Patients are given a bottle of sucrose during the casting process.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care