Open-label exploration of an intravenous nalbuphine and naloxone mixture as an analgesic agent following gynecologic surgery.
OBJECTIVE
The purpose of this series was to explore a 12.5:1 fixed-dose ratio of an intravenous nalbuphine and naloxone mixture (NNM) for use in patients following gynecologic surgery.


METHODS
Open-label, nonrandomized case series. The first series was a dose-ranging investigation for 12 patients following elective total abdominal hysterectomy or myomectomy. In this series, fentanyl was used for intraoperative analgesia, and patients were assigned to a lower NNM (2.5 mg/0.2 mg) or to a higher NNM (5 mg/0.4 mg) dose group. The second series evaluated the fixed dose of 5 mg nalbuphine/0.4 mg naloxone for four patients undergoing ambulatory gynecologic procedures. In the second series, no opioid agents were administered intraoperatively to eliminate the possibility of mu-opioid reversal by naloxone postoperatively.


METHODS
Pain control was assessed using a Verbal Pain Scale (0-10). Vital signs, side effects, and adverse events were recorded to determine drug safety.


RESULTS
In the first series, there were no adverse events; however, each patient required rescue medication (either morphine or fentanyl). In the second series, two of the four patients reported a reduction in pain following drug administration and did not require any further analgesic agents in the 3-hour postoperative period. One patient had an asymptomatic lowering of heart rate after receiving the drug.


CONCLUSIONS
Additional research of the unique combination therapy of nalbuphine and naloxone is warranted to further determine its potential clinical efficacy and safety.
Gordon
Assaf T
AT
Department of Physical Medicine and Rehabilitation, New York University Medical Center, New York, NY 10016, USA.
Levine
Jon D
JD
Dubois
Michel Y
MY
D'Angelo
Robert
R
Conlon
Ann M
AM
Levacic
Danijela
D
Lebovits
Allen
A
D000328:Adult; D000700:Analgesics / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects*; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009266:Nalbuphine / Q000008:administration & dosage*; D009270:Naloxone / Q000008:administration & dosage*; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology
D000700:Analgesics; D004338:Drug Combinations; D009270:Naloxone; D009266:Nalbuphine