Antipyretic Medications

HealthDay News — Use of aromatherapy with peppermint oil after open-heart surgery attenuates pain and improves sleep quality, according to a study published online August 3 in BMJ Supportive & Palliative Care.

Mahla Maghami, from Kashan University of Medical Sciences in Iran, and colleagues conducted a double-blind trial involving 64 patients to examine the effect of inhaling peppermint essence on pain relief and sleep quality after open-heart surgery. Participants were randomly assigned to aromatherapy or placebo in a 1:1 ratio and received inhaled aromatherapy using peppermint essence or distilled water, respectively. The researchers utilized the Numeric Pain Rating Scale and the St. Mary’s Hospital Sleep Questionnaire (a 14-question tool with lower scores indicating better sleep quality).

The researchers found that the mean severity of pain was 3.22 ± 0.88 and 4.56 ± 0.90 in the aromatherapy and placebo groups, respectively, which represented a statistically significant difference. After the intervention, the mean sleep scores were 20.10 ± 4.90 and 25.76 ± 6.36 in the aromatherapy and placebo groups, respectively, on day 1 and 18.63 ± 5.56 and 22.62 ± 5.69, respectively, on day 2; the differences were statistically significant.

“Considering the effect of peppermint essential oil inhalation on pain and sleep quality of patients after open-heart surgery, it can be concluded that this herbal product can be safely used as a complementary treatment in relieving pain and making patients comfortable after heart surgery,” the authors write.

Abstract/Full Text

The Food and Drug Administration (FDA) has expanded the approval of Caldolor^® (ibuprofen injection) to include infants 3 to 6 months of age for the treatment of pain and fever. Previously, the treatment was approved for patients 6 months of age and older.

Caldolor is now indicated for use in adults and pediatric patients 3 months and older for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics. It is also approved for the reduction of fever.

The expanded approval was supported by data from an open-label, non-controlled multicenter study that evaluated the efficacy and safety of Caldolor in 21 hospitalized infants 3 months to less than 6 months of age. Among the 21 patients, 18 were treated with a single dose of Caldolor intravenously.

Use of Caldolor in this patient population was supported by evidence from an open-label and acetaminophen controlled study of fever and additional safety data from 4 studies in 164 pediatric patients, supportive pediatric data from other approved ibuprofen products, and evidence from adequate and well-controlled studies in adults.

Caldolor is supplied in ready-to-use premixed bags containing 800mg of ibuprofen in a 200mL low sodium formulation for injection. It is also available in 800mg/8mL single-dose vials that must be diluted before administration.

“We are delighted to provide Caldolor for these youngest of patients,” said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. “We believe that this approval for the product’s use in infants speaks to Caldolor’s favorable safety profile for use in a growing number of patient populations.”