N/A N=33 Randomized Double-blind Supportive Care

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

Clubfoot

Bottom Line

View on ClinicalTrials.gov: NCT02395185 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: NIPS (Neonatal Infant Pain Scale) — 2.28; 1.63; 1.84; 0.91 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Milk bottle administration (Other); Water bottle administration (Other); Sucrose bottle administration (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Shriners Hospitals for Children
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY NIPS (Neonatal Infant Pain Scale)	2.28; 1.63; 1.84; 0.91; 2.22; 0.63	—
SECONDARY Heart Rate	152.72; 145.69; 155.9; 152.54; 152.59; 154.33	—
SECONDARY Oxygen Saturation	98; 97.52; 98.33; 97.38; 97.56; 94.32	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02395185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.