Postoperative nefopam and diclofenac. Evaluation of their morphine-sparing effect after upper abdominal surgery.

The aim of the study was to assess the relative morphine-sparing effects of nefopam and diclofenac when used singly or in combination after upper abdominal surgery. Eighty-four patients of ASA grade 1 or 2 were allocated randomly to one of three groups. Group A received nefopam 20 mg by intramuscular injection 6 hourly after surgery for the 24-hour study period. Group B received diclofenac 75 mg 12-hourly and placebo injections at 6 and 18 hours after surgery. Group C received both 6-hourly nefopam and 12-hourly diclofenac. Supplemental analgesia was given on demand via a patient-controlled analgesia system which delivered intravenous morphine. Morphine requirements in the diclofenac group were significantly lower than in either of the other groups (p less than 0.01). Patients who received the combination of nefopam and diclofenac required significantly less morphine than those who received nefopam alone (p less than 0.01). Pain scores assessed 6 hours after surgery were significantly lower in the diclofenac and combination groups compared with the nefopam group (p less than 0.01).

The effect of diclofenac and nefopam on postoperative dental pain.

Eighty-two outpatients who received general anaesthesia for surgical removal of maxillary or mandibular third molars were given either diclofenac 75 mg or nefopam 20 mg intramuscularly for postoperative pain control. They and the control group were also allowed oral paracetamol as required. The results showed that there was no significant pain relief from these single intramuscular injections.

Double-blind clinical trial of nefopam in comparison with pentazocine in surgical patients.

A double-blind clinical study comparing a new non-narcotic analgesic, nefopam, with pentazocine was carried out on 50 Indian patients. Forty patients had undergone surgical procedures, and the remaining 10 had musculoskeletal or traumatic disorders. There were 25 patients in each group. It was observed that both drugs were capable of relieving post-surgical pain which was either very severe (score 4) or severe (score 3). Their efficacy was comparable. In patients who had an initial pain score of 4, a significant (p less than 0.05) fall in the sum of pain intensity scores (SPIS) occurred in two days. For an initial pain score of 3, a correspondingly significant fall in SPIS took three days. These results were statistically significant (p less than 0.01). Nefopam had a significantly better side effect profile than pentazocine. In the nefopam group, 4/25 patients had side effects, as opposed to 10/25 in the pentazocine group (p less than 0.05, Fisher's exact probability test). It was also noted that the incidence of side effects was greater in the pentazocine group (61) than the nefopam group (22), the difference being statistically highly significant (p less than 0.001, chi 2-test). A few patients (score 4) in both groups required additional morphine as relief analgesic on the first day of therapy. Thus the non-narcotic nefopam is equally effective as the narcotic pentazocine and has less side effects.

A comparison of nefopam and flurbiprofen in the treatment of osteoarthrosis.

A double-blind cross-over study was undertaken comparing the analgesic nefopam with the NSAID flurbiprofen in the treatment of osteoarthritis of the knees. Thirty patients entered the study and 18 completed the full trial protocol of one month on each drug. There was no significant difference in efficacy between the two treatments, although there were more side effects during the nefopam period. These must be balanced against the known gastrotoxicity of NSAIDs when choosing symptomatic treatment for osteoarthrosis.

Assessment of the analgesic efficacy of nefopam hydrochloride after upper abdominal surgery: a study using patient controlled analgesia.

A randomized, double-blind, placebo-controlled study was performed to assess the analgesic efficacy of intramuscular nefopam hydrochloride after upper abdominal surgery. Patients received either 20 mg nefopam (n = 23) or matching placebo (n = 26), 90 min before surgery, immediately after surgery, and 6, 12 and 18 h after the end of surgery. The 24-h morphine requirements were measured using a patient-controlled analgesia system delivering on-demand intravenous bolus doses of morphine. Pain was assessed using visual analogue scales. Patients receiving nefopam had a mean (+/- s.e.m.) cumulative morphine consumption of 4.1 +/- 0.8 mg in the first hour, compared with 8.5 +/- 0.8 mg in the control group (P less than 0.01). After 24 h the consumptions were 44.1 +/- 7.2 mg and 62.5 +/- 6.9 mg respectively (P less than 0.05). The pain scores in both groups were similar. This study confirms that nefopam hydrochloride has significant analgesic effects and would be a useful supplement to morphine in the management of postoperative pain.

A double-blind study of the simple analgesic nefopam in rheumatoid arthritis.

The role of pure analgesics in the management of rheumatoid arthritis (RA) remains uncertain. In a double-blind cross-over study of 27 patients, nefopam was a more effective analgesic than placebo when given as a supplement to anti-inflammatory drugs. Both early morning stiffness and grip strength were also improved, suggesting that these are associated with pain perception rather than any other aspect of inflammation. Side-effects occurred in 9 (35%) on nefopam and none on placebo. The results suggest a valuable supplementary role for analgesics such as nefopam in the treatment of RA.

Substituted 5H-dibenz[b,g]-1,4-oxazocines and related amino acids with antiinflammatory activity.

During an investigation of the antiinflammatory properties of a number of tetracyclic derivatives of 6,8-dichlorodibenz[b,f]oxepin-10(11H)-one, the ring-expanded 1,3-dichloro-5H-dibenz[b,g]-1,4-oxazocine (9) was prepared and found to be considerable pharmacological interest. It was subsequently found that the corresponding ring-opened amino acid 66, a close analogue of the antiinflammatory agent fenclofenac, also possessed significant antiinflammatory activity, superior both to the dibenzoxazocine and to fenclofenac. These findings prompted extensive synthetic programs in both areas, and a number of derivatives in the amino acid series showed potencies considerably in excess of the standard compound. These phenylacetic acids, however, were significantly more ulcerogenic than fenclofenac whereas the corresponding dibenzoxazocines showed few signs of ulcerogenicity at doses up to 1 g/kg.

Nefopam in postoperative pain.

A comparative study between nefopam (Acupan) and pentazocine was carried out in 90 patients for treatment of postoperative pain following gynaecological operations. The results show that nefopam has an analgesic activity comparable with that of pentazocine, but its duration of action seems to be longer-lasting, even if with a longer period of latency. At equieffective analgesic action, nefopam shows a lower interference with the respiratory function. As far as side-effects are concerned a significant increase in drowsiness was observed with both types of treatment; sweating was observed only in nefopam group.

The need for analgesic cover after ENT surgery--comparison of nefopam and papaveretum.

Intra-operative intramuscular injections of either papaveretum 0.3 mg/kg or nefopam 0.4 mg/kg were given to alternate patients to promote smooth emergence from ENT anaesthesia in a consecutive series of 40 children. Observations over a period of 30 minutes following completion of surgery showed that emergence was satisfactory in 19 out of 20 children given papaveretum, and in 15 out of 20 children given nefopam. The study confirms that this indication for papaveretum is justifiably popular and that nefopam is a useful alternative mainly because it does not cause respiratory depression. There are no previous reports of the use of nefopam in children.

Double blind study with nefopam, tilidine and placebo, for postoperative pain suppression.

A double-blind study involving 101 patients was done to assess the efficacy of parenteral nefopam (0.66 mg/kg) for postoperative pain suppression, in comparison to tilidine (1.67 mg/kg) or placebo. The difference in painfree duration for both active drugs compared to placebo is significant, but no significant difference was present between them; although tilidine was a little longer acting. At no moment a significant difference was present in the pain score of the patients receiving one of both active drugs. Only minor changes of blood pressure, heart rate and respiratory frequency were seen and marked side effects were not present in any of the patients.

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.