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.
Background The pain management of postherpetic neuralgia (PHN) remains a major challenge, with no immediate relief. Nitrous oxide/oxygen mixture has the advantages of quick analgesic effect and well-tolerated. The purpose of this study is to investigate the analgesic effect and safety of nitrous oxide/oxygen mixture in patients with PHN. Methods/design This study is a single-center, two-group (1:1), randomized, placebo-controlled, double-blind clinical trial. A total of 42 patients with postherpetic neuralgia will be recruited and randomly divided into the intervention group and the control group. The control group will receive routine treatment plus oxygen, and the intervention group will receive routine treatment plus nitrous oxide/oxygen mixture. Data collectors, patients, and clinicians are all blind to the therapy. The outcomes of each group will be monitored at baseline (T0), 5 min (T1), and 15 min (T2) after the start of the therapy and at 5 min after the end of the therapy (T3). The primary outcome measure will be the pain intensity. Secondary outcomes included physiological parameters, adverse effects, patients’ acceptance of analgesia, and satisfaction from patients. Discussion Previous studies have shown that nitrous oxide/oxygen mixture can effectively relieve cancer patients with breakthrough pain. This study will explore the analgesic effect of oxide/oxygen mixture on PHN. If beneficial to patients with PHN, it will contribute to the pain management of PHN. Trial registration Chinese Clinical Trial Register ChiCTR1900023730. Registered on 9 June 2019
Background The morbidity of knee arthritis is increasing among aged people and total knee arthroplasty has been its mainstream treatment to date. Postoperative rehabilitation is an important part of the procedure. However, the intense pain during the functional exercise involved has always been a challenge for both patients and health care professionals. The aim of this study is to test the analgesic effect of a mixture of nitrous oxide/oxygeb (1:1) inhalation for patients who are doing functional exercise 1 month after total knee arthroplasty. Methods/design This double-blind, randomized, placebo-controlled study will be implemented in the Rehabilitation Department in the General Hospital of Ningxia Medical University. Patients aged between 50 and 75 years who underwent a primary unilateral total knee arthroplasty are eligible for inclusion. The key exclusion criteria include: epilepsy, pulmonary embolism, intestinal obstruction, aerothorax. The treatment group (A) will receive a pre-prepared nitrous oxide/oxygen mixture plus conventional treatment (no analgesics), and the control group (B) will receive oxygen plus conventional treatment (no analgesics). Patients, physicians, therapists, and data collectors are all blind to the experiment. Assessments will be taken immediately after functional exercise begins (T0), 5 min (T1) after functional exercise begins, and 5 min after functional exercise has finished (T2). Patients will be randomly allocated between a treatment group (A) and a control group (B) in a ratio of 1:1. Primary outcome, including pain severity in the procedure, will be taken for each group. Secondary outcomes include blood pressure, heart rate, oxygen saturation, side effects, knee joint range of motion, Knee Society Score (KSS), rescue analgesia need, and satisfaction from both therapists and patients. Discussion This study will focus on exploring a fast and efficient analgesic for patients who are doing functional exercise after total knee arthroplasty. Our previous studies suggested that the prefixed nitrous oxide/oxygen mixture was an efficacious analgesic for the management of burn-dressing pain and breakthrough cancer pain. The results of this study should provide a more in-depth insight into the effects of this analgesic method. If this treatment proves successful, it could be implemented widely for patients doing functional exercise in the rehabilitation department. Trial registration ChiCTR-INR-17012891 . Registered on 6 October 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3472-7) contains supplementary material, which is available to authorized users.
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.
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