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

NCT02395185 | Completed Results

• 1 other identifier: LEX-102
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clubfoot

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Heart Rate

  Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.

• Oxygen Saturation

  Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting

Study Arms (3)

Milk

EXPERIMENTAL

Milk bottle administration

Other: Milk bottle administration; Other: Water bottle administration; Other: Sucrose bottle administration

Water

EXPERIMENTAL

Water bottle administration

Other: Milk bottle administration; Other: Water bottle administration; Other: Sucrose bottle administration

Sucrose

EXPERIMENTAL

Sucrose bottle administration

Other: Milk bottle administration; Other: Water bottle administration; Other: Sucrose bottle administration

Interventions

Milk bottle administration OTHER

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

Milk; Sucrose; Water

Water bottle administration OTHER

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

Milk; Sucrose; Water

Sucrose bottle administration OTHER

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

Milk; Sucrose; Water

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• idiopathic clubfoot deformity
• undergoing clubfoot casting for correction

You may not qualify if:

• cannot use a bottle for feeding
• on solid food
• have had surgery
• have been given an analgesic within three hours prior to data collection

Sponsors & Collaborators

• Shriners Hospitals for Children: lead
• Kosair Charities, Inc.: collaborator
• University of Kentucky: collaborator

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Rebecca Davis
• Organization: Shriners Hospital for Children

rfdavis@shrinenet.org

859-268-5705

Study Officials

• Todd M Milbrandt, MD

  Shriners Hospital for Children, Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: January 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 15, 2017
• Results First Posted: December 15, 2017

Record last verified: 2017-05