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Aim This study aims to evaluate the safety and analgesic efficacy of pre‐mixed nitrous oxide/oxygen mixture treatment of pain induced by dressing change for perianal abscess. Design This protocol is a randomized, double‐blind, placebo‐controlled trial. Methods This study will be implemented in the Hospital of Traditional Chinese Medicine. Subjects enrolled in this study are hospitalized patients who suffered from moderate to severe pain due to dressing change after incision and drainage. Two hundred patients will be selected and randomly assigned to either an intervention or a control group. The intervention group will get routine pain treatment plus pre‐mixed nitrous oxide/oxygen mixture treatment and the control group will be treated with routine pain management plus medical air treatment. All these patients, medical staff and investigators are blind to the nature of the gas in each cylinder, which is randomized. Data will be collected at baseline (T0), 5 min (T1) after the starting of intervention and 5 min post intervention (T2) for each group. The primary outcome is the level of pain relief at T1 and T2. The secondary outcomes cover physiological parameters, adverse events, satisfaction of patients and health professionals and the acceptance from patients. Discussion Results of this study will be discussed and the safety and effect of nitrous oxide/oxygen treatment of pain induced by dressing change will be proven. Impact When the finding of this study has an active effect on the treatment of pain caused by dressing change, it may provide more options for nursing staff to choose nurse‐led analgesia techniques and then improving the level and quality of pain care as well as patients’ overall satisfaction with the Anorectal Department in China.

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Background:Perianal abscess is mainly treated by surgery in the clinic. However, the pain induced by dressing is the most prominent problem in postoperative patients and available analgesics is limited. The short- acting analgesia, premixed nitrous oxide/ oxygen, may be an ideal analgesic for acute pain induced by dressing change after perianal abscess surgery. This study aims to evaluate the safety and analgesic efficacy of premixed nitrous oxide/oxygen mixture for patients with dressing change after surgery around the anus. Methods/design:This protocol for a randomized, double-blind, placebo- controlled trial will be implemented in the Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University. Study subjects are hospitalized patients underwent perianal abscess surgery and suffered from moderate to severe pain due to dressing. Two hundred subjects will be selected and randomly assigned to other intervention or control group. The intervention group will get regular pain treatment plus premixed nitrous oxide/oxygen and the control group will be treated with regular pain treatment plus oxygen. The patients, medical staffs or investigators are blinded to the nature of the gas mixture in each cylinder and the randomization list. Data will be collected at baseline (T0, 2 min before dressing) and at 5 min (T1) after the beginning of intervention and at 5 min (T2) past dressing. The primary outcome will be the change in pain score at T1 and T2. Secondary outcomes cover physiological parameters, adverse events, patients and medical staffs’ satisfaction as well as patients’ acceptance. Discussion:The findings of this trial will provide a valuable therapeutic regimen for pain caused by dressing after perianal abscess surgery and identify the efficacy and safety of the gas.