OBJECTIVES/HYPOTHESIS: Endoscopic sinus surgery (ESS) is increasingly performed by otorhinolaryngologists. However, the early recovery and pain management after ESS is still largely unexplored. In the present study, we have evaluated the incidence and severity of pain and the efficacy and safety of acetaminophen (paracetamol) for pain management in patients undergoing ESS. STUDY DESIGN: The authors conducted a prospective, double-blind, placebo-controlled clinical trial. METHODS:Seventy-four patients with ESS were randomized to receive either 1 g intravenous acetaminophen (Perfalgan) (n = 36) or 0.9% normal saline as a placebo (n = 38) after ESS was performed under local anesthesia. No other analgesic medication was permitted during the study. Need for rescue analgesic during the first 4 hours after surgery as well as all adverse events were recorded. RESULTS: Most patients, 27 of 38 (71%), in the placebo group needed rescue analgesics but significantly fewer patients in the acetaminophen group required rescue analgesia, i.e., only nine of 36 (25%) patients needed oxycodone. The worst pain after surgery was also more severe in the placebo group than that in the acetaminophen group. There was no significant difference between groups in the incidence of adverse events. The most common adverse events were vomiting, nausea, and headache. CONCLUSIONS:ESS is associated with significant postoperative pain. Acetaminophen provides adequate pain relief in most patients who have undergone ESS. However, the analgesic efficacy of acetaminophen alone is insufficient in some patients, and hence all patients with ESS must be followed closely to identify those patients in need of more efficient analgesia during the early phase of recovery.
RCT Entities:
OBJECTIVES/HYPOTHESIS: Endoscopic sinus surgery (ESS) is increasingly performed by otorhinolaryngologists. However, the early recovery and pain management after ESS is still largely unexplored. In the present study, we have evaluated the incidence and severity of pain and the efficacy and safety of acetaminophen (paracetamol) for pain management in patients undergoing ESS. STUDY DESIGN: The authors conducted a prospective, double-blind, placebo-controlled clinical trial. METHODS: Seventy-four patients with ESS were randomized to receive either 1 g intravenous acetaminophen (Perfalgan) (n = 36) or 0.9% normal saline as a placebo (n = 38) after ESS was performed under local anesthesia. No other analgesic medication was permitted during the study. Need for rescue analgesic during the first 4 hours after surgery as well as all adverse events were recorded. RESULTS: Most patients, 27 of 38 (71%), in the placebo group needed rescue analgesics but significantly fewer patients in the acetaminophen group required rescue analgesia, i.e., only nine of 36 (25%) patients needed oxycodone. The worst pain after surgery was also more severe in the placebo group than that in the acetaminophen group. There was no significant difference between groups in the incidence of adverse events. The most common adverse events were vomiting, nausea, and headache. CONCLUSIONS:ESS is associated with significant postoperative pain. Acetaminophen provides adequate pain relief in most patients who have undergone ESS. However, the analgesic efficacy of acetaminophen alone is insufficient in some patients, and hence all patients with ESS must be followed closely to identify those patients in need of more efficient analgesia during the early phase of recovery.
Authors: Austin T K Hoke; Madison Malfitano; Adam M Zanation; Charles S Ebert; Brent A Senior; Adam J Kimple; Brian D Thorp Journal: J Neurol Surg B Skull Base Date: 2021-12-17
Authors: Hany A Mowafi; Ehab Abou Elmakarim; Salah Ismail; Mohammed Al-Mahdy; Abd Elhady El-Saflan; Ayman S Elsaid Journal: World J Surg Date: 2012-09 Impact factor: 3.352