Randomized Double-Blind Placebo-Controlled Trial of Two Intravenous Morphine Dosages (0.10 mg/kg and 0.15 mg/kg) in Emergency Department Patients With Moderate to Severe Acute Pain
Study objective
We compare pain relief and safety of morphine 0.10 mg/kg with 0.15 mg/kg in adult emergency department (ED) patients with acute pain.
Methods
This was a randomized double-blind placebo-controlled trial of intravenous morphine 0.10 mg/kg versus 0.15 mg/kg, (delivered in 2 divided doses) in adult ED patients with acute pain requiring opioid analgesia. Assessment was made at baseline, 30 minutes, and 60 minutes with a validated verbal numeric rating scale. Pain reduction and satisfaction scores were measured at 30 and 60 minutes. The primary outcome measure was the between-group difference in mean before-after change in numeric rating scale from baseline to 60 minutes.
Results
Two hundred eighty patients were enrolled. Between-group difference in numeric rating scale improvement from baseline to 60 minutes was 0.8 (95% confidence interval 0.1 to 1.5), favoring the 0.15 mg/kg group. Pain relief scores and adverse events were similar in the 2 groups.
Conclusion
Although 0.15 mg/kg of morphine is safe and provides statistically superior analgesia compared with a dose of morphine at 0.10 mg/kg, this difference in pain reduction did not reach the threshold of greater than 1.3 numeric rating scale units required to declare the higher dose of morphine clinically superior.
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Supervising editor: Steven M. Green, MDAuthor contributions: AB, DE, PEB, LH, and EJG conceived the study and designed the trial. DE supervised the conduct of the trial, the research associates, and data collection, including quality control. PB provided statistical advice on study design and analysis of the data. AB analyzed the data. PB conducted the interim analysis. AB drafted the article, and all authors contributed substantially to its revision. AB takes responsibility for the paper as a whole.Funding and support: The authors report this study did not receive any outside funding or support.Available online September 15, 2006.Reprints not available from the authors.
PII: S0196-0644(06)00885-7
doi:10.1016/j.annemergmed.2006.06.030
© 2007 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
