NIH funding opportunities (3) – Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R01, R03, R21)

June 13, 2016 by School of Medicine Webmaster

The following description was taken from the R01 version of this FOA.

Nearly all women during pregnancy experience some sort of pain. Chronic pain includes back pain, abdominal pain, headache, and joint pain, and acute pain commonly occurs following delivery.  Severe and persistent pain which is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure which may lead to complications in pregnancy.  Both over-the-counter (OTC) and prescription pain medicines are used to treat acute and chronic pain during pregnancy, labor delivery and postpartum.  Medicines including acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids are commonly used to reduce/relieve severe and persistent pain. However, there are potential risks of using OTC and prescription medications during pregnancy.

Studies have shown that acetaminophen (both OTC and prescription) may be associated with the risk of attention deficit hyperactivity disorder (ADHD) in children born to women who took this medication during pregnancy.  Whether the use of NSAIDs in early pregnancy may increase the risk of spontaneous abortion is uncertain, as conflicting results have been published from different studies. Second and third trimester NSAID use may also link to neonatal renal impairment in premature infants. The use of aspirin during pregnancy is associated with the risks of fetal and neonatal bleeding and increased risks of adverse effects including persistent pulmonary hypertension of the newborn (PPHN) and renal injury.

A recent epidemiology study has indicated that more than 14% of women in the US take prescription opioids during pregnancy. The rate of use of opioids in pregnancy continues to increase.  However, the safety of using opioids to manage pain and pregnancy outcomes remains unclear. Risks to the fetus may include miscarriage, stillbirth or preterm birth.  Birth defects (neural tube defects) have been associated with opioid exposure during early pregnancy.  The infant is also at increased risk of neonatal abstinence syndrome (NAS). The incidence of NAS continues to rise as it is associated with an increase in the use of opioids by pregnant women.  But data on effective treatment and outcomes of affected infants are insufficient.

Opioids are also routinely used for analgesia and sedation to reduce pain and stress for critically ill children or children born preterm in neonatal and pediatric intensive care units. There has been wide variability in use of outcome measures in different clinical studies/trials, particularly in assessment of pain and its relief, and effects on the neonates. The impact on developing brain of neonatal opioid exposure also remains elusive.

Despite the risks of using pain medications in both pregnant women and children, insufficient data published in the literature has limited the ability of clinicians and pregnant women to make informed decisions on the safe and effective use of these medications. Further research is needed to investigate mechanisms of drug action in pregnant women and children, and underlying effects of drug exposures on placental and fetal development, and to assess pregnancy outcomes (including maternal and child outcomes).


The overall goals of this funding opportunity announcement (FOA) are:

  • To promote preclinical, translational, clinical and epidemiological research in pain medications use in children or in pregnant women to fill knowledge gaps in safe use of the pain medications in these special populations;
  • Develop effective instruments or approaches to assess and evaluate maternal and child outcomes of pain medication treatments.

Studies may use a variety of approaches to address outcomes of pain medication use in children or in pregnant women.  Both animal and human subjects are appropriate for the studies. Specific research topic areas include but are not limited to:

  • Study the effects of prenatal exposure to pain medications on fetal development and pregnancy outcomes;
  • Determine clinical outcomes of analgesic treatment of pregnant women with acute and chronic pain conditions;
  • Assess long-term effects of fetal and neonatal exposures to pain medications;
  • Develop novel tools and technologies to assess and evaluate pain in pregnant women or children;
  • Evaluate and validate existing tools to assess pain management strategies in pregnant women and children.

Deadlines:  standard dates apply


Filed Under: Funding Opportunities