Background: Pharmacologic treatment of postoperative pain after cleft palate repair includes opioids and nonopioid analgesics, nerve blocks, and local anesthetic infiltration. Use of opioids in infants has concerns regarding sedation, risk of aspiration, respiratory depression, and respiratory distress. The main objective of this review was to analyze information available on the safety of the use of opioids during perioperative management of pain related to primary cleft palate repair in published studies. Methods: A systematic review of the literature for studies published until March 2020 was performed to evaluate the safety of opioid drugs during primary cleft palate repair pain management. The authors chose the following MesH terms for this systematic review: cleft lip and palate AND opioids AND pain management. The investigators performed a systematic literature search using the Pubmed/MEDLINE, Embase, Web of Science, and Cochrane Library databases. Results: After a literature search resulting in 70 identified studies, 9 were qualified for the final analysis, which included 772 patients. There was a high level of evidence in the selected studies according to the Oxford CEBM Level of Evidence classification and GRADE scale. The most common adverse event reported was postoperative nausea and vomiting (from 5% to 25%). Episodes of oxygen desaturation have been reported from 2.5% to 7.4% of the studied patients. Conclusion s: Definitive conclusions about the safety of opioid drugs during primary cleft palate repair pain management cannot be drawn. Vomiting and oxygen desaturation have been associated with the use of opioids in the studied population.

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