title: Oral Sucrose for Pain Relief During Clubfoot Casting: A Double-Blinded Randomized Controlled Trial.
abstract: BACKGROUND
  Idiopathic clubfoot treatment is treated by manipulation and casting utilizing the Ponseti technique which can make the infant fussy and irritable. The goal of this study was to determine which intervention could decrease this pain response in infants undergoing Ponseti casting for idiopathic clubfeet. Our hypothesis was that the administration of oral sucrose solution or milk would be the most effective in accomplishing that goal.
  
  
  METHODS
  We conducted a double-blinded randomized controlled trial at a tertiary pediatric orthopaedic center on 33 children (average age=17.94 d; SD=20.51 d) undergoing clubfoot manipulation and casting and their guardians. Each cast was considered a new event and was randomized to an oral 20% sucrose solution (S), water (W), or milk (M) in a bottle (breast or nonbreast). We assessed the Neonatal Infant Pain Scale (NIPS), heart rate, and oxygen saturation before, during, and after the casting.
  
  
  RESULTS
  A total of 131 casts were randomized and 118 analyzed (37 M, 42 S, 39 W). Each child underwent an average of 3.97 casts (SD=1.74). There were no significant differences seen between the groups before casting in their mean NIPS score (M=2.2; SD=2.38, S=1.84, SD=2.18, W=1.61, SD=2.12). However during casting, mean NIPS score for both milk, 0.91 (SD=1.26, P=0.0005) and sucrose, 0.64 (SD=1.27, P<0.0001) were significantly less than water, 2.27 (SD=2.03) but not different from each other (P=0.33). Postcasting, the sucrose NIPS score, 0.69 (SD=1.53) continued to be significantly less than milk, 2.11 (SD=2.37, P=0.0065. There was no correlation between heart rate or oxygen saturation and NIPS.
  
  
  CONCLUSIONS
  Sucrose solution and milk during Ponseti casting and manipulation were effective in decreasing the pain response in children undergoing manipulation and casting for clubfeet. The sucrose solution administration continued the pain relief into the postcasting period. In addition to the benefits of improving the patient experience during casting, a less irritable child may result in better casting.
  
  
  METHODS
  Level 1 evidence.
authors.affiliation: Mayo Clinic, Rochester, MN.
authors.forename: Todd
authors.initials: T
authors.lastname: Milbrandt
authors.affiliation: Department of Orthopaedic Surgery, University of Kentucky, Lexington, KY.
authors.forename: Richard
authors.initials: R
authors.lastname: Kryscio
authors.affiliation: Department of Orthopaedic Surgery, University of Kentucky, Lexington, KY.|Shriners Hospital for Children.
authors.forename: Ryan
authors.initials: R
authors.lastname: Muchow
authors.affiliation: Department of Orthopaedic Surgery, University of Kentucky, Lexington, KY.|Shriners Hospital for Children.
authors.forename: Janet
authors.initials: J
authors.lastname: Walker
authors.affiliation: Department of Orthopaedic Surgery, University of Kentucky, Lexington, KY.|Shriners Hospital for Children.
authors.forename: Vishwas
authors.initials: V
authors.lastname: Talwalkar
authors.affiliation: Department of Orthopaedic Surgery, University of Kentucky, Lexington, KY.|Shriners Hospital for Children.
authors.forename: Henry
authors.initials: H
authors.lastname: Iwinski
mesh_terms: D000284:Administration, Oral; D002370:Casts, Surgical; D003025:Clubfoot / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement / Q000379:methods; D000073818:Procedural Pain / Q000517:prevention & control*; D010290:Parents / Q000523:psychology; D013395:Sucrose / Q000008:administration & dosage*; D013549:Sweetening Agents / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D013549:Sweetening Agents; D013395:Sucrose