Abstract
ObjectiveIntranasal fentanyl (INF) quickly and noninvasively relieves severe pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires vascular access. The trial evaluated the efficacy of INF relative to IVH for treating cancer patients with severe pain in an emergency department (ED) setting.MethodsWe randomized 82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40). Eligible patients reported severe pain at randomization (≥7, scale: 0 “none” to 10 “worst pain”). We conducted non-inferiority comparisons (non-inferiority margin = 0.9) of pain change from treatment initiation (T0) to one hour later (T60). T0 pain ratings were unavailable; therefore, we estimated T0 pain by comparing 1) T60 ratings, assuming similar group T0 ratings; 2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group).ResultsAt T60, the upper 90% confidence limit (CL) of the mean log-transformed pain ratings for the INF group exceeded the mean IVH group rating by 0.16 points (>pain). Substituting randomization ratings for T0 pain, the lower 90% CL of mean pain change in the INF group extended 0.32 points below (<pain relief) mean change in the IVH group. Finally, assuming all subjects in the IVH group had maximum pain at T0 and that T0 pain for the INF group remained unchanged from randomization, the lower bound of the 90% CL for mean pain decrease in the INF group extended 1.37 points below (<pain relief) mean decrease in the IVH group. Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).ConclusionsTwo of three analyses supported non-inferiority of INF versus IVH, while one analysis was inconclusive. Compared to IVH, INF had the advantage of shorter time to administration.Trial registrationClinicalTrials.gov Identifier: NCT02459964
Highlights
Cancer pain is highly prevalent and adversely affects quality of life, making the treatment of pain a crucial part of oncologic care [1]
Compared to intravenous hydromorphone (IVH), Intranasal fentanyl (INF) had the advantage of shorter time to administration
Given the ongoing opioid-abuse epidemic, the American Society of Clinical Oncology (ASCO) has published new guidelines for managing chronic pain in cancer survivors [4]; emergency physicians are shying away from prescribing opioids [5] even though pain is a significant issue for cancer patients presenting to the emergency department (ED) [6]
Summary
Cancer pain is highly prevalent and adversely affects quality of life, making the treatment of pain a crucial part of oncologic care [1]. More than 50% of patients with cancer will experience physical pain, and for 30% of these, the pain will be moderate or severe [2, 3]. Intravenous (IV) hydromorphone titration (the “1+1” protocol) is a safe, well-accepted ED analgesic regimen for patients with severe pain. The regimen involves administering 1 mg of IV hydromorphone followed by an additional 1 mg if requested by the patient. The efficacy of this patient-driven 1+1 hydromorphone protocol has been found to be both clinically and statistically superior to usual care of ED patients with acute severe pain [8]. Other routes of analgesia administration for expeditious pain relief would be desirable
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