NALBUPHINE SUMMARY
NALBUPHINE HYDROCHLORIDE Injection
Nalbuphine Hydrochloride Injection is a sterile, nonpyrogenic solution of nalbuphine hydrochloride in water for injection. This product may be administered by subcutaneous, intramuscular or intravenous injection. Each milliliter (mL) contains nalbuphine hydrochloride 10 mg or 20 mg; sodium citrate, dihydrate 0.47 mg and citric acid, anhydrous 0.63 mg added as buffers and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment; pH 3.7 (3.0 to 4.5). Contains sodium chloride for tonicity adjustment. Multiple-dose vials contain 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives. Single-dose products contain no bacteriostat or antimicrobial agent and unused portions must be discarded.
Nalbuphine hydrochloride is indicated for the relief of moderate to severe pain. Nalbuphine hydrochloride can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.
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NEWS HIGHLIGHTS
Published Studies Related to Nalbuphine
Combination of opioid agonist and agonist-antagonist: patient-controlled analgesia requirement and adverse events among different-ratio morphine and nalbuphine admixtures for postoperative pain. [2008.10]
BACKGROUND: Nalbuphine, a mixed agonist-antagonist opioid, has a potential to attenuate the mu-opioid effects and to enhance the kappa-opioid effects. However, when morphine and nalbuphine are mixed together, the clinical interactions in different combining ratios on analgesic effect and adverse events are unknown... CONCLUSIONS: The interaction between morphine and nalbuphine in PCA admixture on analgesia is additive. Combinations of morphine and nalbuphine in PCA can decrease the incidence of pruritus, and the antipruritus effect is ratio-dependent. This may provide a novel combination strategy of opioid agonist and agonist-antagonist for postoperative pain management after gynaecologic surgery.
Tramadol versus nalbuphine in total intravenous anaesthesia for dilatation and evacuation. [2007.02]
OBJECTIVE: To compare the results of Tramadol with Nalbuphine for dilatation and evacuation with total intravenous anaesthesia technique... CONCLUSION: Quality of analgesia was better in nalbuphine group but both drugs provide suitable analgesic supplementation to TIVA.
Intravenous nalbuphine 50 {micro}g{middle dot}kg-1 is ineffective for opioid-induced pruritus in pediatrics: [La nalbuphine intraveineuse a 50 {micro}g{middle dot}kg-1 est inefficace contre le prurit induit par les opioides chez des enfants]. [2006.11]
PURPOSE: This investigation evaluated the efficacy of nalbuphine in treating postoperative opioid-induced pruritus (Pr) in pediatric patients... CONCLUSION: This preliminary report suggests that nalbuphine 50 mug.kg(-1) iv is not effective in treating postoperative opioid-induced pruritus in pediatric patients. The modified CAS score and PrID warrant further investigation.
A randomized clinical trial of continuous flow nitrous oxide and nalbuphine infusion for sedation of patients during radiofrequency atrial flutter ablation. [2006.04]
CONCLUSION: Inhalation of a (50% N2O/50% O2) mixture during RF ablation for atrial flutter is a safe and efficient way to reduce anxiety and discomfort caused by RF applications.
Prevention of emergence agitation after sevoflurane anesthesia for pediatric cerebral magnetic resonance imaging by small doses of ketamine or nalbuphine administered just before discontinuing anesthesia. [2006.04]
Magnetic resonance imaging (MRI) requires long-lasting immobilization that frequently can only be provided by general anesthesia in pediatric patients...
Clinical Trials Related to Nalbuphine
Nalbuphine for the Treatment of Opioid Induced Pruritus in Children [Active, not recruiting]
Itching is a frequent and disturbing side effect of the use of pain medication such as
morphine. In the post-operative period, it can be more distressing to pediatric patients than
their pain. The current first line treatment, an antihistamine (Benadryl), has a low
efficacy. This treatment causes sleepiness and may be dangerous when used in combination with
other drugs.
Nalbuphine has analgesic properties similar to morphine as well as the ability to reverse
some morphine-induced side effects, such as respiratory depression and itching. Nalbuphine
has been used effectively for patients undergoing Caesarean sections. However, the
effectiveness of nalbuphine in the pediatric population has not been investigated.
We want to determine the efficacy of nalbuphine in the treatment of itching after morphine
for postoperative pain relief. We will use a novel method to measure the effect of the
treatment using an intensity scale before and after the drug, to determine the intensity
difference.
Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity [Not yet recruiting]
In previous clinical studies of post-surgical pain the investigators found that nalbuphine
(Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose
naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was
particularly true in men. The purpose of this study is to find out if nalbuphine combined
with naloxone is more effective in relieving experimentally produced pain than either drug
alone. A second reason for this study is to find out if study medications work more
effectively in women or in men. Subjects will come to the University of California at San
Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be
a 2-hour screening to assess the subject for study eligibility. During the other three
visits, the investigators will use a thermal stimulating device to produce temporary,
non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be
measured following the intravenous (i. v.) administration of study drugs. Three drug
combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and
naloxone 0. 4 mg , 2) naloxone 0. 4 mg and saline (an inactive solution), nalbuphine 5 mg and
saline. These drug combinations will be administered in random order; all subjects will
receive all three combinations.
Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain [Recruiting]
Patients with chronic masticatory muscle pain (i. e., pain greater than three months) or
patients with burning mouth syndrome participate in this study. The aim of the study is to
compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered
with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to
determine if there are sex differences in these two drug regimens. Drugs will be
administered with single-use intranasal spray devices. All participants will receive two
sprays (one spray per nostril). One of the two sprays will be nalbuphine (5 mg). The other
spray will be naloxone in half the participants and placebo in the other half.
The Development of Oral Nalbuphine Dosage Form [Recruiting]
Interaction Between Nalbuphine and Morphine in PCA [Recruiting]
1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
2. This study was designed to investigate the interaction between nalbuphine and morphine
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