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Inhaled nitric oxide had no significant effect on sickle cell disease-related pain crises
Gladwin MT. JAMA. 2011;305:893-902.
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Patients with sickle cell disease who presented to EDs with vaso-occlusive crisis symptoms did not find significant pain relief from the administration of inhaled nitric oxide, researchers found.
This prospective, multicenter, double blind, randomized, placebo-controlled clinical trial was sponsored by Ikaria and the Intramural Research Division of the National Heart, Lung, and Blood Institute, the NIH, and the US Department of Health and Human Services. One hundred and fifty participants presenting with vaso-occlusive pain crises of sickle cell disease at 11 centers from Oct. 5, 2004, to Dec. 22, 2008, were given inhaled nitric oxide or inhaled nitric placebo.
Participants were randomly assigned by site and age (10-15 years, and older than 15 years) in blocks of four in a 1:1 ratio of placebo to inhaled nitric oxide. Randomization was defined at the time a set of study placebo or nitric oxide gas cylinders was opened.
The primary endpoint was the time to resolution of pain and defined by freedom from parenteral opioid use for 5 hours; pain relief determined by visual analog pain scores of 6 cm or less on a 0-10 scale; the patient’s ability to walk; and the patient’s and family’s choice to manage remaining pain at home (with physician’s consent).
“This study used a subjective endpoint because there are no true objective indicators of cessation of crisis,” researchers wrote.
They found no significant difference in outcomes between groups, with a median time to resolution of crisis of 73 hours (95% CI, 46-91) and 65.5 hours (95% CI, 48.1-84), respectively. No significant differences existed in secondary outcomes, including length of hospital stay, visual analog pain scale scores, cumulative opioid usage and rate of acute chest syndrome. Inhaled nitric oxide was not associated with an increase in serious adverse events.
“The results of this study indicate that inhaled nitric oxide in the doses and methods of administration used in this study does not reduce [vaso-occlusive pain crises] severity in [sickle cell disease],” researchers concluded.
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