ADA 2023 guideline on acute dental pain in children: ibuprofen or naproxen over acetaminophen alone, weight before age, and no codeine or tramadol under 12

What it says#

This is the pediatric half of the FDA-funded pair. The same panel that wrote the adult guideline ran a systematic review and meta-analyses on analgesics and corticosteroids in children under 12, graded the evidence with GRADE, and produced seven recommendations and five good practice statements across two conditions: postoperative pain after one or more simple or surgical tooth extractions, and the temporary management of toothache when definitive dental treatment is not immediately available.

The recommendation is the same in both settings. The panel suggests initiating pain management using ibuprofen, as suspension or tablet, alone; or naproxen, over 2 years, as suspension or tablet, alone; or either of the two in combination with acetaminophen, which comes as suspension, tablet, orally disintegrating tablet, caplet or rectal suppository, over the use of acetaminophen alone. If pain control with an NSAID alone is inadequate, add acetaminophen. When NSAIDs are contraindicated, use acetaminophen alone. Every one of those statements is conditional, on very low certainty in the evidence.

The evidence summary explains the hedging. Moderate through very low certainty evidence from four randomized trials suggests ibuprofen alone could decrease the need for rescue analgesia and may reduce pain intensity by a negligible amount at four hours compared with placebo. Five trials suggest acetaminophen alone may reduce pain intensity by a negligible amount at four hours compared with placebo, and five suggest ibuprofen could reduce pain intensity by a negligible amount and may reduce the need for rescue analgesia by an important amount at four hours compared with acetaminophen alone. The single strongest finding is the combination: moderate certainty evidence from one randomized trial indicates that acetaminophen plus ibuprofen likely reduces pain by an important amount compared with either alone. Low to very low certainty evidence from a single trial suggests acetaminophen with codeine may produce a trivial reduction in pain intensity compared with placebo, acetaminophen alone or ibuprofen alone. The review found no direct evidence on naproxen in children; the panel reasoned from trials in adolescents and adults, where ibuprofen and naproxen sodium are among the most effective analgesics for acute dental pain, and judged there was no clinical reason to expect naproxen to be less effective in children. That is why naproxen over 2 years appears here as an off-label use: the FDA approves naproxen for acute use from age 12, and for prescription use in polyarticular juvenile idiopathic arthritis from age 2.

The dosing is weight first. The chairside guides state plainly that when defining dosages, weight should be the primary directive as opposed to age. Ibuprofen, for infants and children up to and including 11 years under 50 kg: 4 to 10 mg/kg per dose every 6 to 8 hours as needed, maximum single dose 400 mg, maximum 40 mg/kg in 24 hours. Acetaminophen, for infants and children up to and including 11 years: 10 to 15 mg/kg per dose every 4 to 6 hours as needed, maximum 75 mg/kg in 24 hours but not to exceed 4,000 mg in 24 hours; the guides note that both short- and long-term doses are associated with hepatotoxicity, which is why products are limited to 325 mg per dosage unit. Naproxen over 2 years: under 60 kg, 5 to 6 mg/kg every 12 hours as needed; 60 kg and over, 250 to 375 mg every 12 hours as needed; maximum daily dose 1,000 mg for naproxen and 1,100 mg for naproxen sodium, with 200 mg of naproxen base equivalent to 220 mg of naproxen sodium. The guides also print band tables by weight and age, reproduced in the figure above. All of it is professionally prescribed dosing rather than over-the-counter labeling, and the treating dentist decides the dose for the child in the chair.

Two drugs are off the table entirely. According to the FDA, codeine and tramadol are contraindicated in children younger than 12 years, and topical benzocaine should not be used in infants or young children because of the high risk of methemoglobinemia, which is the subject of its own FDA warning, covered in fda-benzocaine-teething-warning-2018. There is no opioid step in this document at all. The good practice statements add that clinicians should assess a child's pain with a tool suited to age, naming a behavioral scale for 1 to 3 years, a Faces scale from 3 years, and a numerical rating scale or visual analog scale from 8 years; should counsel the child and caregiver that some pain is expected and the analgesics should make it manageable; should discuss past experiences, preferences and values before prescribing; and should review medical and social histories, medications and supplements to avoid overdose and drug interactions.

Who it applies to#

Children younger than 12, treated by general dentists, pediatric dentists and anyone else who sends a child home after extractions or sees one in pain without immediate access to treatment. The panel is careful that not every extraction in a child needs an analgesic at all: the recommendation applies when there is unresolved postoperative pain, when several teeth come out in one session, or when a surgical extraction involved osteotomy or soft tissue manipulation. Adolescents 12 and over belong to the companion document, ada-acute-dental-pain-adults-2024, which does carry an opioid second line and asks for extreme caution in exactly that age band. The toothache recommendations apply only where definitive treatment is not immediately available; where it is, the instruction is to do it.

Like its companion, the guideline states that it is intended to inform clinical decision making by prescribers and patients and is not intended to be used to restrict, limit, delay or deny coverage for or access to a prescription issued for a legitimate medical purpose. This entry reports a guideline; the prescriber decides.

What changed#

First edition, and the direction of the change is away from acetaminophen as the reflex and away from codeine combinations altogether. The panel's comparator throughout is acetaminophen alone, and its recommendation is an NSAID instead, alone or with acetaminophen added. The codeine trial it found produced only a trivial reduction in pain, and the FDA contraindication settles the question for children under 12. The other change is procedural: dosing moves from age bands to weight, with the age column on the chairside guide as a cross-check rather than the input.

Where the source is#

The link under the title opens the guideline's author manuscript in PubMed Central, PMC10910586, which carries the full text, the two recommendation boxes with their strength and certainty, the summary of main findings and the remarks; jada.ada.org refused automated access in this session, so that is where the text above was read. The published article is JADA 2023;154(9):814-825.e2, PMID 37634915. The two pediatric chairside guides, which carry the dosing tables reproduced in the figure, are PDFs on the ADA's acute dental pain guideline page, copyright 2024 American Dental Association, University of Pittsburgh and University of Pennsylvania, released under CC BY-NC-ND 4.0 for noncommercial education and research; licensing for commercial use runs through the Innovation Institute at the University of Pittsburgh. The project was financially supported by FDA grant U01FD007151, and the guides state that their contents do not represent an official view of or endorsement by the FDA, HHS or the United States government.