title: Analgesia effect of a fixed nitrous oxide/oxygen mixture on burn dressing pain: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Procedural burn pain is the most intense acute pain and most likely type of burn injury pain to be undertreated due to the physician's fear of the adverse effect of analgesia and lack of anesthetist present. At our institution, in most of the cases, local burn detersion and debridement were performed at the ward level without any analgesics. This article describes a study designed to test the analgesia effect of a fixed nitrous oxide/oxygen mixture on burn dressing pain.
  
  
  METHODS
  The experiment was carried out in three centers. The patients were given a number from 1 to 240. A randomization list was produced by a statistician according to our preliminary study. Due to the severity of the pain suffered, ethically it was decided to help as many as possible, so patients given the letters A, B or C were treated using a canister with the appropriate letter containing preprepared nitrous oxide/oxygen mixture (NOOM). Those with D were given oxygen only, from an identical-looking canister labeled D. Neither patients, nor doctors, nor nurses, nor data collector knew what was in each canister, thus they were all blind. The nursing officer who implemented the intervention handed the doctors envelopes containing the patients' name and allocation of A, B, C or D. Thus, patients receiving NOOM or oxygen were in the ratio 3:1. Parameters, including pain severity, blood pressure, heart rate, digital oxygen saturation and the Chinese version of the burn specific pain anxiety scale (C-BSPAS), were taken before, during and after dressing for each group. A video and audio record was taken individually for later communication coding and outcome analysis. Rescue analgesic was recorded.
  
  
  CONCLUSIONS
  Based on the findings from our previous qualitative study that physician's reluctance to order narcotic analgesia is due to its adverse effect and from our pilot experiment, this study aims to test the hypothesis that a fixed nitrous oxide/oxygen mixture will promote better burn dressing pain alleviation and outcomes. Analyses will focus on the effects of the experimental intervention on pain severity during dressing (primary outcomes); physiological parameters, C-BSPAS and acceptance of both health care professionals and patients (secondary outcomes). If this model of analgesia for burn pain management implemented by nurses proves successful, it could potentially be implemented widely in hospital and prehospital settings and improve patients' satisfaction and quality of life.
  
  
  BACKGROUND
  (Clinical Trials Identifier: CHICTR-TRC11001690).
authors.affiliation: Department of Nursing, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai 200433, China.
authors.forename: Li
authors.initials: L
authors.lastname: Yuxiang
authors.forename: Tang
authors.initials: T
authors.lastname: Lu
authors.forename: Yu
authors.initials: Y
authors.lastname: Jianqiang
authors.forename: Dai
authors.initials: D
authors.lastname: Xiuying
authors.forename: Zhou
authors.initials: Z
authors.lastname: Wanfang
authors.forename: Zhang
authors.initials: Z
authors.lastname: Wannian
authors.forename: Hu
authors.initials: H
authors.lastname: Xiaoyan
authors.forename: Xiao
authors.initials: X
authors.lastname: Shichu
authors.forename: Ni
authors.initials: N
authors.lastname: Wen
authors.forename: Ma
authors.initials: M
authors.lastname: Xiuqiang
authors.forename: Wu
authors.initials: W
authors.lastname: Yinsheng
authors.forename: Yao
authors.initials: Y
authors.lastname: Ming
authors.forename: Mu
authors.initials: M
authors.lastname: Guoxia
authors.forename: Wang
authors.initials: W
authors.lastname: Guangyi
authors.forename: Han
authors.initials: H
authors.lastname: Wenjun
authors.forename: Xia
authors.initials: X
authors.lastname: Zhaofan
authors.forename: Tang
authors.initials: T
authors.lastname: Hongtai
authors.forename: Zhao
authors.initials: Z
authors.lastname: Jijun
mesh_terms: D000280:Administration, Inhalation; D000700:Analgesics / Q000008:administration & dosage*; D001458:Bandages / Q000009:adverse effects*; D002056:Burns / Q000150:complications / Q000523:psychology / Q000628:therapy*; D002681:China; D004311:Double-Blind Method; D006801:Humans; D009609:Nitrous Oxide / Q000008:administration & dosage*; D010100:Oxygen / Q000008:administration & dosage*; D010146:Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014741:Video Recording
chemical_list: D000700:Analgesics; D009609:Nitrous Oxide; D010100:Oxygen