Nalbuphine nasal spray on par with injectable solution in orthopaedic procedures

The nalbuphine nasal spray Apain may be used as a safe and noninvasive alternative to intramuscular nalbuphine for the relief of severe pain in patients who underwent orthopaedic interventions and traumatological procedures, suggests a study.

“Designed for self-administration and dose-adjusting, the noncontrolled opioid analgesic nalbuphine spray can be used for patient-controlled analgesia in out-of-hospital, field, and home settings,” the investigators said.

This double-blind, randomized study enrolled 90 orthopaedic and traumatology patients to determine the effectiveness and tolerance of a single 10.5-mg dose of nalbuphine nasal spray versus a 10-mg intramuscular injection.

The investigators then calculated the summed pain intensity difference (SPID_0–6), the primary endpoint, using visual analogue scale scores.

Of the patients, 79 were included in the per-protocol efficacy population. Six patients in the reference group and five in the test group were excluded due to remedication.

The mean values of the endpoints in the reference and test groups were 228.08 (95 percent confidence interval [CI], 205.73‒250.43) vs 248.73 (95 percent CI, 225.83‒271.63) for SPID_0–6, 0.28 h (95 percent CI, 0.25–0.31) vs 0.27 h (95 percent CI, 0.25–0.29) for time to pain relief onset, and 5.55 h (95 percent CI, 5.17–5.93) vs 5.51 h (95 percent CI, 5.10–5.92) for analgesia duration, respectively.

The area under the curve was 119.30 (95 percent CI, 91.17‒147.43) in the reference group and 99.81 (95 percent CI, 74.52‒107.10) in the test group. No statistically significant differences were observed between the two arms.

“Our previous 3-period crossover study in healthy volunteers comparing the pharmacokinetics of nalbuphine nasal spray Apain with parenteral nalbuphine solution demonstrated high bioavailability of the nasal spray and close similarity of pharmacokinetic profiles after intranasal and intramuscular administration, especially within 30 min postdose,” the investigators said.