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

• ClinicalTrials.gov Identifier: NCT02395185
• Recruitment Status: Completed
• First Posted: March 20, 2015
• Results First Posted: December 15, 2017
• Last Update Posted: December 15, 2017
• Sponsor: Shriners Hospitals for Children
• Collaborators: Kosair Charities, Inc.; University of Kentucky
• Information provided by (Responsible Party): Todd Milbrandt, Shriners Hospitals for Children

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Clubfoot	Other: Milk bottle administration; Other: Water bottle administration; Other: Sucrose bottle administration	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants
• Study Start Date: January 2013
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Milk; Milk bottle administration	Other: Milk bottle administration; Patients are given a bottle of milk during the casting process.; Other: Water bottle administration; Patients are given a bottle of water during the casting process.; Other: Sucrose bottle administration; Patients are given a bottle of sucrose during the casting process.
Experimental: Water; Water bottle administration	Other: Milk bottle administration; Patients are given a bottle of milk during the casting process.; Other: Water bottle administration; Patients are given a bottle of water during the casting process.; Other: Sucrose bottle administration; Patients are given a bottle of sucrose during the casting process.
Experimental: Sucrose; Sucrose bottle administration	Other: Milk bottle administration; Patients are given a bottle of milk during the casting process.; Other: Water bottle administration; Patients are given a bottle of water during the casting process.; Other: Sucrose bottle administration; Patients are given a bottle of sucrose during the casting process.

Outcome Measures

Primary Outcome Measures :

1. NIPS (Neonatal Infant Pain Scale) [ Time Frame: 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 Outcome Measures :

1. Heart Rate [ Time Frame: 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.
2. Oxygen Saturation [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: up to 6 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Shriners Hospitals for Children

Kosair Charities, Inc.

University of Kentucky

Investigators

• Principal Investigator: Todd M Milbrandt, MD; Shriners Hospital for Children, Mayo Clinic

More Information

• Responsible Party: Todd Milbrandt, MD, Shriners Hospitals for Children
• ClinicalTrials.gov Identifier: NCT02395185
• Other Study ID Numbers: LEX-102
• First Posted: March 20, 2015
• Results First Posted: December 15, 2017
• Last Update Posted: December 15, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Clubfoot; Talipes; Equinus Deformity; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities