Cochrane for Clinicians

Putting Evidence into Practice

Acetaminophen for the Treatment of Pain in Newborns


Am Fam Physician. 2016 Aug 1;94(3):216-217.

Author disclosure: No relevant financial affiliations.

Clinical Question

Is acetaminophen an effective treatment for neonates with pain caused by medical procedures?

Evidence-Based Answer

Acetaminophen does not significantly reduce pain associated with heel lance, eye examinations, or assisted vaginal births in newborns. Acetaminophen may reduce the total amount of morphine a newborn needs in the first 48 hours following major abdominal or thoracic surgery. (Strength of Recommendation: B, based on inconsistent or limited quality patient-oriented evidence.)

Practice Pointers

Neonates are often exposed to painful interventions during routine newborn care or complicated neonatal intensive care unit hospitalizations. Pharmacologic therapies for pain relief include opiates, benzodiazepines, anesthetics, nonsteroidal anti-inflammatory drugs, and acetaminophen, and nonpharmacologic therapies include oral sweet solutions, sucking, swaddling, and kangaroo care.13 Despite increased awareness of the importance of pain prevention, the effectiveness and safety of these modalities remain controversial, and they may be underused for the treatment of pain in neonates.3

The authors of this Cochrane review identified eight studies evaluating the effectiveness of acetaminophen for the treatment of pain in 614 neonates (30 days or younger). Pain was measured by validated tools examining newborn facial actions, body movements, cry, heart rate, and/or oxygen saturation. The painful procedures included heel lance, assisted vaginal birth, eye examination for retinopathy of prematurity, and postoperative care following abdominal or thoracic surgery.

In infants undergoing heel lance, oral acetaminophen (20 mg per kg) did not significantly reduce pain compared with sterile water, lidocaine/prilocaine (EMLA) cream, or cherry elixir. At higher doses of 40 mg per kg, oral acetaminophen was no more effective than sterile water at reducing pain. Oral glucose solution appeared to be more effective than oral acetaminophen (20 mg per kg) at reducing pain scores

Author disclosure: No relevant financial affiliations.


1. Hall RW. Anesthesia and analgesia in the NICU. Clin Perinatol. 2012;39(1):239–254.

2. McPherson C, Grunau RE. Neonatal pain control and neurologic effects of anesthetics and sedatives in preterm infants. Clin Perinatol. 2014;41(1):209–227.

3. American Academy of Pediatrics Committee on Fetus and Newborn, American Academy of Pediatrics Section on Surgery, Canadian Paediatric Society Fetus and Newborn Committee, Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update [published correction appears in Pediatrics. 2007;119(2):425]. Pediatrics. 2006;118(5):2231–2241.

These are summaries of reviews from the Cochrane Library.

This series is coordinated by Corey D. Fogleman, MD, Assistant Medical Editor.

A collection of Cochrane for Clinicians published in AFP is available at



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