Context. Leukemia is the most common cancer in the childhood population. Lumbar puncture (LP) plays central role in the diagnosis and treatment process, but options for analgesia are limited.Objectives. The present study aims to evaluate the efficacy of a fixed N 2 O/O 2 mixture to reduce pain in children with leukemia during LP as compared with placebo.Methods. A double-blind, placebo-controlled, and randomized clinical trial involving children who needed LP for diagnosis or treatment was conducted in the pediatrics department of the General Hospital of Ningxia Medical University. Eligible patients were randomly assigned to inhale either a fixed N 2 O/O 2 mixture or O 2 . The primary endpoint was the maximal pain level felt by the patient during the procedure measured using a numerical rating scale (0e10).Results. One-hundred fourteen consecutive patients were enrolled in this study and randomized. Pain scores during the procedure showed a significant decrease in N 2 O/O 2 mixtureetreated patients to 1.05 AE 1.40 versus 8.00 AE 2.13 in controls (P < 0.01). No serious adverse effects were attributed to N 2 O/O 2 mixture inhalation. Analysis of the satisfaction of patients receiving N 2 O/O 2 mixture indicated that medical staff were satisfied with this treatment.Conclusions. This study demonstrated that self-administered fixed N 2 O/O 2 is efficient to reduce pain related to LP in children with leukemia.
BackgroundThe management of breakthrough pain in cancer patients is always a challenge for medical professions. Occurring in 80% of cancer patients with advanced disease, breakthrough pain significantly decreases both patient’s and caregiver’s quality of life. The aim of this study is to assess the analgesic efficacy of a fixed inhaled nitrous oxide/oxygen mixture for adult cancer patients with breakthrough pain.Methods/designThis is a randomized, placebo-controlled, double-blind study; it will be conducted in the General Hospital of Ningxia Medical University. The target study subjects are at least 18 years old, and are hospitalized cancer patients who are receiving routine opioids to control cancer-related pain but still experience breakthrough pain. A total of 240 patients will be recruited and randomly allocated between three treatment groups (A, B, C) and a control group (group D) in a ratio of 3:1. All treatment groups (A, B, C) will receive standard pain treatment (oral immediate-release morphine) plus a pre-prepared nitrous oxide/oxygen mixture, and the control group (D) will receive the standard pain treatment plus oxygen. Patients, doctors, nurses, and data collectors are all blind to the experiment. Assessments will be taken before treatment (T0), at 5 min (T1) and 15 min (T2) during treatment, and at 5 min after treatment (T3). The primary endpoint measures will be the percentage of patients whose pain is relieved at T1, T2, and T3. Secondary outcome measures will include the safety of treatment, adverse events, and satisfaction from both health professionals and patients.DiscussionThis study aims to provide an effective and practical intervention for a fast breakthrough pain relief and to improve cancer patients’ quality of life significantly. The Evidence-Based Medicine Working Group claim that a randomized, double-blind, placebo-controlled experimental intervention is the most appropriate design to demonstrate its efficacy, so this study could give a new approach to controlling breakthrough pain episodes.Trial registration
ChiCTR-INC-16008075. Registered on 8 March 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1739-9) contains supplementary material, which is available to authorized users.
The management of breakthrough cancer pain is always a challenge due to its temporal characteristics of rapid onset, moderate to severe in intensity, short duration (median 30-60 min). Our study find that self-administered nitrous oxide/oxygen mixture was effective in reducing moderate to severe breakthrough cancer pain.
ObjectiveTo obtain in-depth insight into the perceptions of parents and paediatricians in China regarding current procedural pain management on bone marrow aspirations and lumbar punctures in paediatric haemato-oncology department.Design, setting and participantsThis qualitative study was conducted in a 4500-bed university hospital in northwest China. To collect data, in-depth semistructured interviews were conducted with parents of children with acute leukaemia (n=12) and haemato-oncology paediatricians (n=11) using purposive sampling. Interviews were audiotaped and transcribed and subjected to thematic analysis.ResultsThe suffering of procedural pain among paediatric patients was not adequately recognised and properly treated at the paediatric haemato-oncology department. The current paediatric procedural pain management is inadequate for paediatric patients. Crucial factors were identified including lack of awareness about the damage of uncontrolled pain in children, parents’ low supportive ability, the limited capacity to provide general analgesia by anaesthetists, inadequate knowledge in the usage of analgesia and sedation and lack of efficient analgesic for children’s procedural pain. The participants strongly expected optimal interventions to improve paediatric procedural pain management.ConclusionsThe result suggested a perceived and actual poor management of paediatric procedural pain in haemato-oncology department in northwest China. A relevant pain management education programme for paediatricians and parents as well as an effective pain medication are urgently needed in northwest China.Trial registrationChinese Clinical Trial Registry. Identifier: ChiCTR-INR-16007989.
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