A Fixed Nitrous Oxide and Oxygen Mixture for Analgesia in Children With Leukemia With Lumbar Puncture–induced Pain: A Randomized, Double-blind Controlled Trial

Abstract

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.

Pre‐mixed nitrous oxide/oxygen mixture treatment of pain induced by postoperative dressing change for perianal abscess: Study protocol for a randomized, controlled trial

“…Its analgesic effects have been known for nearly two centuries. Studies (Li et al, 2013; Liu, Gao, Dai, Li, et al, 2018; Liu et al, 2019) have confirmed the safety and efficacy of pre‐mixed nitrous oxide for treatment of cancer patients with breakthrough pain, leukaemia children with pain induced by lumbar puncture, adults with burn wound dressing. The main advantage of the analgesic gas is that it cannot cause loss of consciousness and patients can control gas flow on their own (Maslekar, 2009).…”

“…Those who agreed to engage in this study and signed the form will be randomly allocated into two groups (intervention and control group). Patients in both groups will receive inhale pre‐mixed nitrous oxide/oxygen or medical air treatment with a one‐way valve, specially designed oral–nasal mask (Qiang et al, 2019). These patients hold the self‐administered mask that can be controlled by their negative pressure to inhale the gas during the dressing change.…”

“…In this study, we design that the intervention group will get nitrous oxide/oxygen mixture plus routine pain therapy compared with the control group who receives medical air plus routine pain therapy. Studies have indicated that inhalation of these two gases is a safe intervention strategy with no severe adverse effects on patients (Yu‐Xiang et al, 2013; Liu, Gao, Dai, Li, et al, 2018; Qiang et al, 2019). Even if any undesired events happen during the nitrous oxide/oxygen or medical air intervention, mild and short‐lived and they usually disappear when patients are exposed to the air (Maslekar, 2009).…”

“…The expert will not be involved in the recruitment, gas distribution, data collection of this study. The list will be sealed and stored in a designated research office to ensure concealment (Qiang et al, 2019). To maintain a double‐blind environment, nurses and researchers are blind and not allowed to touch envelope lists unless they can put forward justifiable reason and get the approval from the project supervisor.…”

“…The determination of sample size was based on our previous studies involved with burn‐dressing pain, pain induced by lumbar puncture and cancer breakthrough pain (Li et al, 2013; Liu, Gao, Dai, Li, et al, 2018; Liu et al, 2019). With the preliminary data observed of 20 patients at T2 in the AD, it indicates that about 80% of patients who receive pre‐mixed nitrous oxide/oxygen treatment have a significant reduction in pain score (a drop at least one‐third of pain score (Salas et al., 2014)) versus 10% of patients treated with medical air.…”