A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants

NCT ID: NCT02395185

Last Updated: 2017-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-10-31

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.

Conditions

Clubfoot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Milk

Milk bottle administration

Group Type: EXPERIMENTAL

Milk bottle administration

Intervention Type: OTHER

Patients are given a bottle of milk during the casting process.

Water bottle administration

Intervention Type: OTHER

Patients are given a bottle of water during the casting process.

Sucrose bottle administration

Intervention Type: OTHER

Patients are given a bottle of sucrose during the casting process.

Water

Water bottle administration

Group Type: EXPERIMENTAL

Milk bottle administration

Intervention Type: OTHER

Patients are given a bottle of milk during the casting process.

Water bottle administration

Intervention Type: OTHER

Patients are given a bottle of water during the casting process.

Sucrose bottle administration

Intervention Type: OTHER

Patients are given a bottle of sucrose during the casting process.

Sucrose

Sucrose bottle administration

Group Type: EXPERIMENTAL

Milk bottle administration

Intervention Type: OTHER

Patients are given a bottle of milk during the casting process.

Water bottle administration

Intervention Type: OTHER

Patients are given a bottle of water during the casting process.

Sucrose bottle administration

Intervention Type: OTHER

Patients are given a bottle of sucrose during the casting process.

Interventions

Milk bottle administration

Patients are given a bottle of milk during the casting process.

Intervention Type: OTHER

Water bottle administration

Patients are given a bottle of water during the casting process.

Intervention Type: OTHER

Sucrose bottle administration

Patients are given a bottle of sucrose during the casting process.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kosair Charities, Inc.

OTHER

Sponsor Role: collaborator

University of Kentucky

OTHER

Sponsor Role: collaborator

Shriners Hospitals for Children

OTHER

Sponsor Role: lead

Responsible Party

Todd Milbrandt

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Todd M Milbrandt, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospital for Children, Mayo Clinic

Other Identifiers

LEX-102

Identifier Type: -

Identifier Source: org_study_id