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.
Published Studies Related to Nalbuphine
Pharmacokinetics of nalbuphine hydrochloride after intravenous and intramuscular administration to Hispaniolan Amazon parrots (Amazona ventralis). [2011.06]
OBJECTIVE: To assess the pharmacokinetics of nalbuphine HCl after IV and IM administration to Hispaniolan Amazon parrots (Amazona ventralis). ANIMALS: 8 healthy adult Hispaniolan Amazon parrots of unknown sex...
Antinociceptive effects of nalbuphine hydrochloride in Hispaniolan Amazon parrots (Amazona ventralis). [2011.06]
OBJECTIVE: To evaluate the antinociceptive effects and duration of action of nalbuphine HCl administered IM on thermal thresholds in Hispaniolan Amazon parrots (Amazona ventralis). ANIMALS: 14 healthy adult Hispaniolan Amazon parrots of unknown sex...
Comparison between tramadol hydrochloride & nalbuphine hydrochloride in the treatment of per-operative shivering after spinal anaesthesia. [2011.04]
Per-operative shivering following spinal anaesthesia is a common problem in the operation theatre.This study was also done to observe the incidence of shivering during operation following spinal anesthesia.
Efficacy of intramuscular nalbuphine versus diphenhydramine for the prevention of epidural morphine-induced pruritus after cesarean delivery. [2011.03]
BACKGROUND: Pruritus is the most common side effect of epidural morphine analgesia. Diphenhydramine is a widely used agent for the treatment of urticarial pruritus. Nalbuphine is a mixed opioid agonist-antagonist and has been reported to be effective in treating opioid-induced pruritus. We compared the effectiveness of intramuscular diphenhydramine and nalbuphine for the prevention of epidural morphine-induced pruritus after cesarean section... CONCLUSION: Nalbuphine proved better than diphenhydramine for prevention of epidural morphine-induced pruritus in patients who underwent cesarean section. Prophylactic intramuscular nalbuphine (10 mg) is effective in decreasing the incidence and severity of pruritus and does not affect analgesia.
Effect of treatment with a topical ophthalmic preparation of 1% nalbuphine solution on corneal sensitivity in clinically normal horses. [2010.02]
OBJECTIVE: To assess the effect of treatment with a topical ophthalmic preparation of 1.2% nalbuphine solution on corneal sensitivity in clinically normal horses... The topical ocular treatment was not associated with local irritation.
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
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
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.
Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally [Recruiting]
The pathophysiology of sickle cell disease (SCD) manifestations, are complex with
interactions of intracellular hemoglobin, membrane and endothelial activation but the
hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful
episodes are thought to result from ischemia caused when small blood vessels are occluded by
misshapen, inflexible erythrocytes. Painful episodes are the most common cause of
hospitalization, morbidity, and impairment for SCD patients. There is no therapy that
completely prevents or directly aborts painful events for all patients. Consequently,
treatment for acute VOC is primarily supportive using hydration and medicinal pain control.
Every pain medication has the potential to relieve pain but is associated with significant
limitations and side effects.
The primary hypothesis to be tested in this double blind, randomized controlled trial is
that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer
episodes of acute chest syndrome. The investigators also expect subjects will report fewer
side effects from respiratory depression, abdominal distention from reduced peristalsis,
reduced histamine release causing pruritis and still be provided adequate pain control.
Further hypotheses to be tested is ability to recruit patient participants while being
treated in the Emergency Department and that continuous infusion of Nalbuphine with
accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain,
requiring less total opiates consumption, while decreasing length of hospitalization.
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus [Recruiting]
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER
tablets during a treatment period of up to 24 weeks.