Evaluation of Hydrocodone/Acetaminophen for Pediatric Laceration Repair: A Randomized Trial

Plast Reconstr Surg. 2020 Jan;145(1):126e-134e. doi: 10.1097/PRS.0000000000006383.


Background: Laceration repair is a common procedure, and causes pain and distress in children. The purpose of this study was to measure the effect of hydrocodone/acetaminophen elixir in reducing both pain and anxiety in children undergoing sutured laceration repair in the emergency department.

Methods: The authors conducted a randomized, double-blinded, placebo-controlled trial in children aged 2 to 17 years, stratified by age younger than 8 years, with topical lidocaine-treated lacerations requiring sutured repair in the emergency department. The primary outcome was pain score at 5 minutes of laceration repair. Secondary outcomes included progression to procedural sedation and anxiety scores in older children.

Results: Eighty-five children were randomized, 43 to the hydrocodone/acetaminophen group and 42 to the placebo group. Median 5-minute pain scores in children aged 2 to 7 years were significantly lower in the medication group (5.0; interquartile range, 4.0 to 6.50) compared with the placebo group (7.0; interquartile range, 5.25 to 10.0; p = 0.01). Three patients (12 percent) in the placebo group proceeded to procedural sedation. For children aged 8 to 17 years, there was no significant difference in pain scores between the treatment (0.5; interquartile range, 0.0 to 0.1; p = 0.81) and placebo groups (0.1; interquartile range, 0.01 to 0.4) or in anxiety scores using the State-Trait Anxiety Inventory for Children.

Conclusion: Adjuvant oral hydrocodone/acetaminophen is more effective than placebo in reducing pain in children younger than 8 years undergoing topical lidocaine-treated laceration repair, but it does not decrease pain or anxiety in older children.

Clinical question/level of evidence: Therapeutic, II.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acetaminophen / therapeutic use*
  • Administration, Topical
  • Adolescent
  • Age Factors
  • Anxiety / diagnosis
  • Anxiety / etiology
  • Anxiety / prevention & control*
  • Anxiety / psychology
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Drug Combinations
  • Emergency Service, Hospital
  • Female
  • Humans
  • Hydrocodone / therapeutic use*
  • Lacerations / surgery*
  • Lidocaine / administration & dosage
  • Male
  • Pain Measurement
  • Pain, Procedural / diagnosis
  • Pain, Procedural / etiology
  • Pain, Procedural / prevention & control*
  • Pain, Procedural / psychology
  • Plastic Surgery Procedures / adverse effects*
  • Plastic Surgery Procedures / psychology
  • Prospective Studies
  • Treatment Outcome


  • Drug Combinations
  • acetaminophen, hydrocodone drug combination
  • Acetaminophen
  • Hydrocodone
  • Lidocaine