Objective To explore the effects of temperature-controlled continuous cooling on early maxillary swelling, bleeding, pain, comfort and the incidence of non-freezing injury in patients after maxillary Le Fort Ⅰ osteotomy orthognathic surgery. Methods Sixty-three patients after maxillary Le Fort Ⅰ osteotomy orthognathic surgery were randomized into an experimental group (n=33) and a control group (n=30), who were applied temperature-controlled continuous cooling and intermittent cooling respectively within 6 hours after the surgery. Results The swelling progression before and after cooling in the experimental group was significantly less than that in the control group, and the comfort score during cooling was significantly higher than that in the control group (P＜0.05 for both), there were no significant differences in the dosage of hemostatic drugs and analgesics, and the incidence of non-freezing injuries between the two groups (P＞0.05 for all). Conclusion The temperature-controlled continuous cooling can effectively relieve early maxillary swelling and increase the comfort of patients after maxillary Le Fort Ⅰ osteotomy orthognathic surgery, and it doesn′t cause skin injury.