Analgesic effectiveness of acetaminophen for primary cleft palate repair in young children: a randomized placebo controlled trial.
BACKGROUND
Clefting of the lip, palate, or both is a common congenital abnormality. Inadequate treatment for pain in children may result from concerns over opioid-related adverse effects. Providing adequate pain control with minimal adverse effects remains challenging in children.


OBJECTIVE
To assess opioid-sparing effects of oral or intravenous acetaminophen following primary cleft palate repair in children.


METHODS
Prospective randomized controlled trial in 45 healthy children, ages 5 months to 5 years, using standardized general anesthesia and lidocaine infiltration of the operative field. Patients were allocated to groups: intravenous acetaminophen/oral placebo (intravenous), oral acetaminophen/intravenous placebo (oral), or intravenous/oral placebo (control). Groups were compared for differences in opioid administration during the 24-h study period (morphine equivalents µg·kg(-1) ; 95% confidence interval).


RESULTS
Intravenous acetaminophen decreased opioid requirement after surgery (P = 0.003). Patients in the intravenous group received less opioid (272.9; 202.9-342.8 µg·kg(-1) ) than control patients (454.2; 384.3-524.2 µg·kg(-1) ; P < 0.002). Opioid requirement in oral patients (376.5; 304.1-448.9 µg·kg(-1) ) was intermediate and not significantly different from either intravenous (P = 0.11) or control (P = 0.27). During the ward phase of care, intravenous had better analgesia than control (P = 0.002), and both intravenous and oral group patients received less opioid than control (P = 0.01).


CONCLUSIONS
Intravenous acetaminophen given to young children undergoing primary cleft palate repair was associated with opioid-sparing effects compared to placebo. The fewer morphine doses during ward stay in both intravenous and oral may be important clinically in some settings.
Department of Anesthesiology, Loma Linda University School of Medicine, Loma Linda, CA, USA.
Chelan
C
Nour
Joanna
J
Ratsiu
Neeta
N
Singh
Linda
L
Mason
Andrea
A
Ray
Mark
M
Martin
Mohammad
M
Hassanian
Jacob
J
Uhler
Richard L
RL
Applegate
D000082:Acetaminophen / Q000627:therapeutic use*; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D002675:Child, Preschool; D002972:Cleft Palate / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010147:Pain Measurement / Q000187:drug effects; D010149:Postoperative Pain / Q000188:drug therapy*; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen
acetaminophen; cleft palate; congenital abnormalities and syndromes; pain PACU; pain miscellaneous