As described in the Annals of Emergency Medicine online April 20, Dr. Andrew K. Chang and colleagues conducted a prospective randomized trial of a fixed “1+1” hydromorphone protocol against usual care of emergency department patients with acute severe pain.
The 167 patient assigned to the 1+1 group received 1 mg hydromorphone immediately and a second 1-mg dose 15 minutes later if they said “yes” to the question, “Do you want more pain medication?” The 171 patients assigned to usual care received an initial dose of an IV opioid as determined by the ED attending physician, who also decided on any subsequent additional analgesics.
Patients who experienced oxygen desaturation of less than 95% were given 4 L of nasal cannula oxygen. All patients were asked again at 60 minutes if they wanted more pain medication.
Successful treatment was defined as not requesting additional analgesia at 15 minutes or 60 minutes. On an intention-to-treat basis, 86.8% (145/167) of patients randomized to the 1+1 group were successfully treated versus 76.6% (131/171) of usual care patients.
In the 1+1 group, 156 received the second dose of hydromorphone and 144 of them were successfully treated. The per-protocol success rate was therefore 144/156 or 92.3%, the researchers note.
One patient in the 1+1 group and two in the usual care group had transient oxygen desaturation, according to the report, and the incidence of all adverse effects was similar in both groups.
“When analyzed per protocol or with the more conservative intention-to-treat analysis,” Dr. Chang and colleagues conclude, “the 1+1 hydromorphone protocol is statistically and clinically more efficacious than usual care.”
The journal editor points out in a summary of the study, “An ED care pathway using this simple regimen could allow safe and easily deployable analgesia.”
Randomized Clinical Trial Comparing the Safety and Efficacy of a Hydromorphone Titration Protocol to Usual Care in the Management of Adult Emergency Department Patients With Acute Severe Pain
Ann Emerg Med 2011.