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PubMed2005

Median effective dose (ED50) of nefopam and ketoprofen in postoperative patients: a study of interaction using sequential analysis and isobolographic analysis.

BACKGROUND: The analgesic efficacy of ketoprofen has been shown after moderate- and severe-pain surgery, and the analgesic efficacy of nefopam has been shown after moderate-pain surgery. The aim of this study was to define the median effective analgesic doses of each drug and to determine whether the interaction of nefopam and of ketoprofen is synergistic. METHODS: Seventy-two patients scheduled to undergo moderately painful surgery were enrolled in one of three groups. The dose of nefopam and ketoprofen received by a particular patient was determined by the response of the previous patient of the same group, using an up-and-down technique. Initial doses were 18 and 40 mg, with dose adjustment intervals of 2 and 5 mg, in the nefopam and ketoprofen groups, respectively. The initial doses of nefopam and ketoprofen were 8 and 20 mg, respectively, in the nefopam-ketoprofen group, with the same dose adjustment intervals. Analgesic efficacy was defined as a decrease to less than 3 on a 0-10 numeric pain scale, 45 min after the beginning of drug infusion. RESULTS: The median effective analgesic dose (median value and 95% confidence interval) of nefopam and ketoprofen were, respectively, 28 mg (17-39 mg) and 30 mg (14-46 mg). The median effective analgesic dose of the combination was 1.75 mg (0.9-2.3 mg) for nefopam and 4.3 mg (2.2-6.5 mg) for ketoprofen. CONCLUSION: The isobolographic analysis demonstrated that the combination of the two drugs produces effective analgesia with an important synergistic interaction.

Adult↗

PubMed1987

Antinociceptive effects of (+/-)-, (+)- and (-)-nefopam in mice.

The antinociceptive activity of (+/-)-, (+)- and (-)-nefopam in mice has been examined using the hot-plate, formalin and tail-flick tests. Nefopam was administered by the intraperitoneal, intracerebroventricular (i.c.v.) and intrathecal (i.th.) routes. Intraperitoneal injection of (+/-)-nefopam (10-20 mg kg-1) had powerful analgesic effects in the hot-plate and formalin tests. In the tail-flick test it produced a weak, but significant elevation of the response latencies. In spinalized animals, however, the effect was abolished, indicating that nefopam prolonged the tail-flick latencies by activation of descending pain-modulating pathways. (+/-)-Nefopam (5-20 micrograms) elicited analgesia in the hot-plate test after i.c.v. or i.th. injection. These findings suggest that nefopam has both a spinal and a supraspinal site of action. (+)-Nefopam was significantly more potent than (-)-nefopam after both systemic and central administration.

Analysis of Variance↗

PubMed2004

The median effective dose of nefopam and morphine administered intravenously for postoperative pain after minor surgery: a prospective randomized double-blinded isobolographic study of their analgesic action.

UNLABELLED: The aim of this study was to characterize the nature of analgesic interaction between nefopam and morphine administered i.v. for postoperative pain after minor surgery. To do so, we defined the median effective analgesic dose (ED(50)) for each drug and also the median ED(50) of their combination and compared them using the isobolographic method. Determination of median effective doses was performed by the up-and-down sequential drug administration in a two-stage study. First, in a prospective, randomized, double-blinded study, we enrolled 60 patients with mild to moderate pain after minor surgery; this was followed by an open study enrolling 30 patients. The end-point was a pain score less than 3 on a Numerical Pain Scale (0-10). Initial doses were 16 mg in group N, 5 mg in group M, and 7.5 mg of N combined with 2.5 mg of M in group N+M. The testing interval was 2 mg in group N, 1 mg in group M, and 1.5 mg of N combined with 0.5 mg of M in group N+M. ED(50) (95% confidence interval) was 5 mg (4-6 mg) for morphine, 18 mg (16-18 mg) for nefopam, and 4 mg (3.5-4.5 mg) with 12 mg (10.5-13.5 mg) for the combination of morphine and nefopam administered at a 3:1 dose ratio. Isobolographic analysis demonstrated a significant infra-additive interaction. The incidence of side effects did not differ significantly among morphine, nefopam, and their combination. These findings suggest that the combination of nefopam and morphine does not offer any advantage compared to each drug administered i.v. or alone after minor surgery. This study is the first to define the ED(50) of nefopam and morphine in postoperative patients. In conclusion, the addition of nefopam has a morphine-sparing effect, but the combination is infra-additive. IMPLICATIONS: Pharmacologic interaction between nefopam and morphine shows infra-additivity but their combination may be clinically useful as morphine consumption is decreased in postoperative patients.

Adult↗

PubMed2002

Nefopam abuse.

OBJECTIVE: To report 3 patients who abused nefopam, a central analgesic that inhibits serotonin, norepinephrine, and dopamine reuptake. CASE SUMMARIES: CASE 1: A 42-year-old white woman with migraines started nefopam therapy about 10 years ago. She now obtains nefopam by prescription forgery and self-administers intramuscular nefopam 300 mg/d. She experiences anticholinergic effects of nefopam and, when attempting withdrawal, depressive symptoms. CASE 2: A 40-year-old white woman with osteoporosis has injected 120 mg of nefopam intramuscularly daily for several years. When she tried to increase doses due to worsening of her symptoms, she experienced tremor, involuntary movements, and dry mouth, and became aggressive. She then resumed the initial doses. She now reports symptoms of depression when attempting withdrawal. CASE 3: A 33-year-old white man, with a history of alcohol and benzodiazepine dependence and ileostomy, and an implanted drug delivery system, has been prescribed nefopam. Fifteen days after therapy was initiated, his daily consumption was 840 mg/d, and further increased to 1840 mg/d. He experienced violent behavior, agitation, facial dysesthesia and myoclonus, tremor of fingers, and sweating. He did not attempt withdrawal. DISCUSSION: The patients described above are drug-dependent according to the Diagnostic and Statistical Manual, 4th Edition. All patients developed a pharmacodynamic tolerance phenomenon, which can develop rapidly. Violent behavior, tremor after massive intake, and depressive symptoms during withdrawal are similar to those reported with psychostimulant abuse. CONCLUSIONS: When abused, nefopam has primarily psychostimulant-like effects, which are probably linked to its dopamine reuptake inhibition properties.

Adult↗

PubMedDate not supplied

Capacity of two forms of activated charcoal to adsorb nefopam in vitro and to reduce its toxicity in vivo.

The adsorption of nefopam hydrochloride to two different charcoals was studied in vitro at pH 1.2 and 7.4. Both forms of activated charcoal effectively adsorbed nefopam, but the adsorption was significantly (p less than 0.001) more complete to PX-21 than to Norit A and the neutral pH favored adsorption over the acid pH. The unadsorbed fraction increased steeply when the charcoal-to-nefopam ratio was decreased below 5. In mice, the administration of Norit A and PX-21 (1700 mg/kg) significantly (p less than 0.001) increased the acute LD50 of nefopam hydrochloride, by 4.3 fold and 5.8 fold, respectively. The calculated amounts of free drug in the gastrointestinal tract are in good agreement with the observed LD50 values without charcoal when the free fractions at pH 1.2 and the corresponding charcoal-to-nefopam ratios in vitro are used in the calculations. The antagonism of charcoal to nefopam toxicity was confirmed in rats, too. At charcoal-to-nefopam ratios higher than those used in the present study, an even more effective reduction of toxicity is obvious. Therefore, immediate oral administration of a high dose (50-100 g) of activated charcoal is highly recommended to prevent nefopam absorption in acute intoxications in man, too.

Adsorption↗

PubMed1997

Efficacy of nefopam for the prevention and treatment of amphotericin B-induced shivering.

BACKGROUND: Shivering is experienced by up to 70% of patients undergoing amphotericin B therapy. Treatment with meperidine hydrochloride, currently the most widely used medication for controlling amphotericin B-induced shivering, was compared with nefopam hydrochloride, which has been successfully used to treat post-operative shivering. METHODS: Forty-five patients with cancer and systemic fungal infections randomly received nefopam hydrochloride, 0.3 mg/kg, meperidine hydrochloride, 0.7 mg/kg, or saline solution intravenously 15 minutes before the cessation of amphotericin B infusion (1 mg/kg for 45 minutes). If shivering persisted, patients in the control (saline solution) group received either nefopam hydrochloride, 0.3 mg/kg, or meperidine hydrochloride, 0.7 mg/kg. RESULTS: Occurrence of shivering 15 minutes after the cessation of amphotericin B infusion was significantly less frequent in the nefopam (6.6%) and meperidine (40%) groups compared with the control group (66.6%). The incidence of shivering in the nefopam group with respect to the meperidine group was also significantly reduced. Moreover, nefopam administration to 5 persistently shivering patients in the control group definitively stopped the shivering in all of them (100%) in a mean (+/- SD) time of 29.1 +/- 4.8 seconds, while meperidine terminated shivering in 4 (80%) of 5 patients in a mean (+/- SD) time of 200.0 +/- 30.2 seconds. The adverse reactions that can be ascribed to nefopam or meperidine use were nausea and sedation, respectively, and may be considered negligible. CONCLUSION: Nefopam seems to be more effective than meperidine in preventing and quickly suppressing amphotericin B-induced shivering.

Adult↗

PubMed2000

Nefopam enantiomers: preclinical pharmacology/toxicology and pharmacokinetic characteristics in healthy subjects after intravenous administration.

Nefopam (NEF) is a potent analgesic compound administered as a racemic mixture. Previous in vitro and in vivo studies with nefopam enantiomers have shown that (+)nefopam [(+)NEF] is substantially more potent than (-)nefopam [(-)NEF]. Differences between enantiomers have also been suggested in metabolic studies in vitro. The impact of these differences in vivo is not known because there is little or no information on the relative plasma concentrations of the enantiomers or on their kinetics. In this study, individual enantiomers of nefopam were synthesized and examined for acute toxicity in male and female rats and mice. Pharmacologic properties of enantiomers were examined using in vitro binding assays and antinociceptive tests in rats and mice. Additionally, a pharmacokinetic study was conducted in human volunteers. Subjects were administered 20 mg nefopam as Acupan(R) either as a 5- or 20-min intravenous infusion. In a control phase, subjects were administered only vehicle. Blood samples were collected through the following 24 h. Plasma samples were analyzed for individual enantiomers using a chiral assay developed for this purpose. The pharmacologic differences of previous studies were confirmed in receptor binding assays and in the hot plate and the formalin tests in mice. Neither enantiomer demonstrated substantial activity in the tail flick test in rats. No significant differences were revealed between LD(50) values of nefopam enantiomers after oral or intravenous administration in male and female rats or mice. There were no significant differences in AUC(0-infinity), C(max), or half-life between enantiomers following intravenous administration. Based on these findings, there is currently no compelling rationale to justify administering or monitoring individual enantiomers.

Analgesics, Non-Narcotic↗

PubMed1986

Evidence of the involvement of dopamine in the analgesic effect of nefopam.

The involvement of brain monoamines in the mechanism of action of nefopam, a new analgesic, was investigated in rats. The study was designed to evaluate the effect of various means of impairing monoaminergic transmission on nefopam analgesia as measured with the hot plate method. Pretreatment with reserpine (2 mg/kg) significantly reduced the antinociceptive action of nefopam (40 mg/kg), indicating that the interaction of this drug with the monoaminergic systems is important for its effects. A role for serotonin (5-HT) or norepinephrine (NE) was ruled out by the fact that selective depletion of 5-HT (using 5,7-dihydroxytryptamine) or NE (using DSP-4 or FLA-63) did not affect nefopam analgesia. A significant reduction of the effect of nefopam was found in rats pretreated with 6-hydroxydopamine (6-OHDA). Also 6-OHDA plus desipramine, which selectively depleted brain DA, markedly reduced the antinociceptive effect of nefopam. The data strongly suggest that a critical dopaminergic synapse is involved in the mechanism by which nefopam inhibits nociceptive responses in rats.

5,7-Dihydroxytryptamine↗

PubMed2002

Effects of nefopam on the spinal nociceptive processes: a c-Fos protein study in the rat.

We have evaluated the effects of nefopam on the spinal c-Fos protein expression in the model of acute (noxious heat) and persistent (intraplantar injection of formalin) nociception in the rat. One and two hours after i.pl. formalin injection, c-Fos immunoreactive (c-Fos-IR) nuclei were preferentially located in the superficial (I-II) and deep (V-VI) laminae of the spinal dorsal horn of segments L4-L5, i.e. spinal areas containing numerous neurons responding exclusively, or not, to peripheral nociceptive stimuli. The doses of 15 and 30 mg/kg (s.c.) of nefopam had significant reducing effects on the formalin-evoked spinal c-Fos protein expression (36+/-14% and 47+/-9% reduction of the total number of c-Fos-IR nuclei per section, respectively, P<0.05 for both). These reducing effects of nefopam were not detectable 2 h after formalin. These results provide evidence that the significant effects of nefopam are time-limited in the formalin model of persistent nociception. One hour after noxious heat stimulation (52 degrees C for 15 s), c-Fos-IR nuclei were principally located in the superficial laminae I-II of the spinal dorsal horn (about 90% of the total number of c-Fos-IR nuclei per section). Nefopam (15 mg/kg s.c.) significantly reduced the noxious heat-evoked spinal c-Fos protein expression (33+/-3% reduction of the total number of c-Fos-IR nuclei, P<0.0001). The present results provide first evidence for the reducing effects of nefopam on the noxiously evoked spinal c-Fos protein expression, principally in acute nociceptive processes. These results suggest that nefopam may produce antinociceptive effects mainly in acute pain states.

Analgesics, Non-Narcotic↗

PubMed1980

Nefopam and propoxyphene in episiotomy pain.

To evaluate relative efficacy, safety, and time course of analgesia, nefopam (45 and 90 mg), a new centrally acting nonnarcotic analgesic, was compared with propoxyphene (65 mg) and placebo in a single oral dose, parallel, stratified, randomized, double-blind trial with 100 hospitalized postpartum women with medium or severe episiotomy pain. Using subjective reports as indices of response, patients rated pain intensity and side effects at periodic interviews for 6 hr. After 45 and 90 mg nefopam, 21 of 25 and 20 of 25 patients (p less than 0.01) reported more than 50% reduction of pain, whereas after 65 mg propoxyphene 18 of 25 (p less than 0.05) and after placebo 11 of 25 reported reduction in pain. Relative efficacy, based on summed pain intensity differences, showed measurable but modest dose-dependent analgesia with nefopam, suggesting that the effectiveness of 65 mg propoxyphene lay between 45 mg nefopam and placebo. Side effects included mild dizziness and hypothermia after nefopam and mild elevation of diastolic arterial pressure after nefopam and propoxyphene. Our results suggest that 45- and 90-mg doses of nefopam induced more analgesia than 65 mg propoxyphene in the relief of episiotomy pain.

Adolescent↗

PubMed2001

Analgesic efficacy and safety of nefopam vs. propacetamol following hepatic resection.

In order to compare the morphine-sparing effect, analgesic efficacy and tolerance of nefopam and propacetamol given at their highest recommended doses, 120 patients undergoing elective hepatic resection were randomly assigned to receive postoperative intravenous patient-controlled analgesia with morphine alone, or in combination with nefopam (20 mg.4 h-1) or propacetamol (2 g.6 h-1). Compared with the control group (43 [7-92] mg), median [range] cumulative morphine consumption for 24 h after the study started was halved in the nefopam group (21 [3-78] mg, p <0.001) and 20% lower in the propacetamol group (35 [6-84] mg, p = 0.15). Analgesia was superior in the nefopam group despite the lower morphine consumption. Adverse effects were comparable in the three groups, except for significantly more nausea in the control group (39% vs. 17 and 26% in the nefopam and propacetamol groups, respectively) and more sweating in the nefopam group (17% vs. 0 and 3% in the control and propacetamol groups, respectively). Overall patient satisfaction was better (p < 0.001) in patients given nefopam (97%) than those receiving morphine alone (82%) or propacetamol (74%).

Acetaminophen↗

PubMed1998

[Prophylactic nefopam administration for post-anesthetic shivering].

PURPOSE: Shivering is a frequent postanaesthetic complication. Its definite reason is unknown. Patients with cardiovascular or pulmonary diseases are endangered by postanaesthetic shivering. The aim of this study was to assess the efficacy of nefopam in prophylaxis of shivering. Additionally we investigated the influence of nefopam on haemodynamic parameters and on the time until extubation. METHODS: 30 patients (ASA I-II) were randomly allocated in a double-blind fashion to one of two groups to receive directly after the end of isoflurane application either nefopam (0.15 mg/kg) or placebo (0.9% saline). The period of anaesthesia had to be longer than 60 minutes. All patients received a premedication with lorazepam (0.02 mg/kg) 30-45 minutes prior to surgery. Induction of anaesthesia was standardised: fentanyl (3 micrograms/kg), thiopentone (5 mg/kg), atracurium (0.4 mg/kg). Intraoperatively a mixture of isoflurane, nitrous oxide (60%) and oxygen was used to maintain anaesthesia. The following parameters were evaluated: Age, sex, duration of operation and anaesthesia and the time between the end of application of volatiles and extubation. Heart rate (HR), mean arterial blood pressure (MAP), rectal temperature and O2-saturation were measured at predefined data points. Postoperatively the consumption of analgesic was documented. The severity of shivering was classified in five grades. RESULTS: In the control-group nine patients shivered (60%), whereas in the nefopam group only one patient (6.6%) shivered (p < 0.05). In comparison to the placebo group we observed in the nefopam group a significantly decreased HR 30 and 60 minutes postoperatively (p < or = 0.007 and p < or = 0.002). We did not observe prolonged awakening in the nefopam-treated patients. MAP and O2-saturation showed similar reactions in both groups. CONCLUSION: The data indicate that prophylactic administration of nefopam can suppress postanaesthetic shivering. Prolonged awakening was not observed.

Analgesics, Non-Narcotic↗

PubMed2003

Randomized prospective study of the analgesic effect of nefopam after orthopaedic surgery.

BACKGROUND: Balanced postoperative analgesia combines non-narcotic drugs and opioids. We organized a large study to evaluate nefopam analgesia and tolerance in combination with morphine for patient-controlled analgesia (PCA) after orthopaedic surgery. METHODS: Two hundred and one patients scheduled to undergo hip arthroplasty were included in this multicentre (n=24), double-blind, randomized study comparing nefopam (20 mg every 4 h for 24 h) with placebo, the first dose being infused peroperatively. The primary outcome measure was the cumulative morphine dose received postoperatively by PCA over 24 h. Secondary outcome measures were the amount of morphine received as a loading dose in the postanaesthesia care unit (PACU) and during the 24-h observation period, and pain assessments using a visual analogue scale (VAS) and a verbal pain scale (VPS), patient's satisfaction with analgesia and treatment tolerance. RESULTS: The two groups were comparable with respect to their characteristics and preoperative pain assessment. PCA-administered morphine over 24 h was significantly less for the nefopam group than the control group (21.2 (15.3) and 27.3 (19.2) mg respectively; P=0.02). This morphine-sparing effect was greater (35.1%) for patients with severe preoperative pain (VAS>30/100). For the entire study period (loading dose and PCA), morphine use was less for the nefopam group (34.5 (19.6) vs 42.7 (23.6) mg; P=0.01). Pain VAS at PACU arrival and during the whole PACU period was significantly lower for the nefopam than for the placebo group (P=0.002 and 0.04 respectively). Patient satisfaction was similar for the nefopam and placebo groups. CONCLUSION: In combination with PCA morphine, nefopam gives significant morphine-sparing with lower immediate postoperative pain scores without major side-effects. This analgesic effect seems to be particularly notable for patients with intense preoperative pain.

Adult↗

PubMed1975

Nefopam and morphine in man.

A new analgesic, nefopam, is chemically distinct and pharmacologically unrelated to any presently known analgesic. A comparison was made of morphine and nefopam in 74 patients who required parenteral analgesia for moderate to severe postoperative and somatic pain, using a single administration, 2-dose level, double-blind design. A significant dose-response curve was obtained with nefopam and with morphine, and there was no significant deviation from parallelism. The time-effect curves for the 2 drugs were similar. The estimated relative potency of nefopam to morphine indicates that 20 mg of nefopam HCl is the approximate analgesic equal of 12 mg of morphine SO4. There were no adverse effects with nefopam and one adverse reaction to morphine.

Adult↗

PubMed1976

Controlled clinical trial of oral and parenteral nefopam hydrochloride. A novel and potent analgesic drug.

The results of a controlled, double-blind clinical trial are reported demonstrating the potency of analgesia produced by orally and parenterally administered nefopam HCl in hospitalized patients with pain principally of skeletal and neuromuscular origin. The drug is an analogue of orphenadrine, consisting of a cyclization of the diphenhydramine molecule. A double-blind, crossover study was made of the analgesic effects of intramuscular doses of 20 mg nefopam HCl, 50 mg pethidine, and saline placebo in 20 patients. Nefopam and pethidine were found to be equally effective and statistically superior to placebo. A double-blind, randomized study was made of orally administered nefopam HCl, 60 mg t.i.d., for three days and of placebo t.i.d. for three days in 80 patients. Nefopam was distinctly superior to placebo in analgesic effectiveness, both in the initial single dose and in maintaining therapeutic benefit for the duration of the three-day trial. It was concluded that nefopam is a potent analgesic of novel structure and unique physiologic properties.

Adult↗

PubMed1979

Comparison of the discriminative stimulus properties of nefopam and morphine.

Separate groups of rats were trained to discriminate nefopam or morphine from saline in a two-lever operant task. Nefopam produced saline-appropriate responding in morphine-trained rats. The highest dose of morphine tested in nefopam-trained rats produced responding appropriate for neither training treatment. This intermediate morphine responding was antagonized by a naloxone treatment that had no effect on the nefopam discrimination. These results suggest that the stimulus properties of nefopam and morphine are qualitatively different but also that morphine produces effects related to those that result in stimulus control by nefopam.

Animals↗

PubMed1994

Modulation of nitric oxide effects by flurbiprofen enantiomers and nefopam and its relation to antinociception.

We have examined the interactions of the analgesics, R- and S-flurbiprofen and nefopam, with nitric oxide (NO) in several experimental systems. Phenylephrine-precontracted rat aortic strips with intact endothelium were relaxed by R- and S-flurbiprofen and nefopam in a concentration-dependent manner. Removal of endothelium, inhibition of guanylate cyclase, inhibition of NO biosynthesis and inactivation of NO significantly reduced these relaxations. R- and S-flurbiprofen as well as nefopam enhanced the inhibition of platelet aggregation caused by rat peritoneal neutrophils or 3-morpholinosydnonimine. The antinociceptive effects of R- and S-flurbiprofen in the mouse writhing test as well as those of nefopam in the hot plate test were not significantly affected by administration of NO synthase inhibitors. We conclude that the increase in the biological activity of NO by R- and S-flurbiprofen and nefopam does not play a major role in the antinociceptive activity of the drugs, but might contribute to acute hypotension, a side-effect occasionally seen with flurbiprofen and nefopam.

Analgesics↗

PubMed2006

Role of catecholamines and serotonin receptor subtypes in nefopam-induced antinociception.

The non-opiate analgesic nefopam has been shown to inhibit monoamines uptake, but little is known about receptor subtypes effectively involved in its analgesic effect. In vitro binding assays yielded the following measures of affinity (IC(50)): serotonergic 5-HT(2C) (1.4 microM), 5-HT(2A) (5.1 microM), 5-HT(3) (22.3 microM), 5-HT(1B) (41.7 microM), 5-HT(1A) (64.9 microM), adrenergic alpha(1) (15.0 microM) and dopaminergic D(1) (100 microM). Subcutaneous nefopam administration dose-dependently inhibited pain in acetic acid-induced writhing (1-30 mg kg(-1)) and formalin (1-10 mg kg(-1)) tests in the mouse. Pretreatments with adrenergic alpha(1) (prazosin) and alpha(2) (yohimbine), and serotonergic 5-HT(1B) (GR127935) receptor antagonists significantly increased the nefopam ED(50) in the writhing test. The serotonergic 5-HT(2C) (RS102221) and the dopaminergic D(2) (sulpiride) receptor antagonists inhibited nefopam antinociception in the formalin test. However, in both tests, nefopam analgesic activity was not modified by the following receptor antagonists: dopaminergic D(1) (SCH23390), serotonergic 5-HT(1A) (NAN-190, WAY100635), 5-HT(2A) (R96544, ketanserin), 5-HT(3) (tropisetron), and 5-HT(4) (SDZ205557). In conclusion, nefopam analgesic activity could be modulated by the adrenergic alpha(1) and alpha(2) receptors, the dopaminergic D(2) receptors, and the serotonergic 5-HT(1B) and 5-HT(2C) receptor subtypes.

Adrenergic alpha-1 Receptor Antagonists↗