Butorphanol: A Double-Blind Comparison with Pentazocine in Post-Operative Patients with Moderate to Severe Pain

1976 ◽  
Vol 4 (4) ◽  
pp. 255-264 ◽  
Author(s):  
M S Gilbert ◽  
R S Forman ◽  
D S Moylan ◽  
F S Caruso

A double-blind, randomized trial was conducted with 124 post-operative patients to compare the analgesic activity and possible side-effects of a new synthetic analgesic—butorphanol tartrate (1, 2, and 4 mg)—and pentazocine lactate (30 and 60 mg), administered intramuscularly. Butorphanol was determined to be 16 times more potent than pentazocine, on a weight basis. Both medications provided maximum pain relief within one hour after administration, and had comparable durations of action. Drowsiness was the most common side-effect, and it appeared to be dose-related in all test groups.

1972 ◽  
Vol 1 (1) ◽  
pp. 26-29 ◽  
Author(s):  
S G Flavell Matts

In a double-blind cross-over comparison of two mild analgesic compound tablets patients in moderate or severe pain showed a significant preference for the pentazocine-paracetamol compound tablet. Side effects were of a minor nature only and no patient dropped out of the trial because of them. It is concluded that significantly more patients (p <0.01) prefer the pentazocine-paracetamol compound to the dextropropoxyphene-paracetamol compound.


1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).


1974 ◽  
Vol 2 (2) ◽  
pp. 149-152 ◽  
Author(s):  
B Kay

A double-blind between-patient study involving 225 adult patients was carried out to compare the efficacy of oral aspirin ( 650 mg), dextropropoxyphene (65 mg) and pentazocine ( 50 mg) in post-operative pain. All the patients were initially in moderate or severe pain and all three drugs produced some degree of pain relief. The onset of action of pentazocine was significantly more rapid than that of aspirin or dextropropoxyphene. The analgesia provided by dextropropoxyphene was significantly inferior to that achieved with aspirin or pentazocine and the duration of action, assessed by patient demand for further analgesic drugs, was also significantly shorter than that of the other two drugs. The incidence and severity of side-effects was greatest in the dextropropoxyphene group and it is concluded from these results that pentazocine should be the oral analgesic of choice in the treatment of post-operative pain.


1982 ◽  
Vol 10 (2) ◽  
pp. 104-108 ◽  
Author(s):  
A G Wade ◽  
Peter J Ward

The results of treating acute or chronic pain with Distalgesic were compared in a double-blind fashion with the new partial antagonist analgesic meptazinol. Both drugs had similar analgesic time effect profiles and both were acceptable to doctor and patients. However the side-effect profile was better for meptazinol than Distalgesic and so meptazinol may be a useful alternative to Distalgesic in the treatment of everyday pain states.


1979 ◽  
Vol 7 (2) ◽  
pp. 147-151 ◽  
Author(s):  
Louis F Fabre ◽  
David M McLendon ◽  
Arthur Mallette

This study compared prazepam with diazepam, chlorazepate dipotassium, and placebo in the treatment of anxious out-patients. Patients were screened for participation in the study to be sure they met the criteria for inclusion. Patients were excluded if they had complicating physical or mental problems. All patients signed an informed consent. Seventy-three patients entered the study, thirteen did not complete at least two weeks of treatment and were not used in the data analysis. Of these thirteen, ten did not return and were lost to follow-up, two entered the hospital for reasons unrelated to the drug study, and one patient on diazepam was terminated because of increased anxiety. Sixty patients were used in the data analysis, thirty-six males and twenty-four females with an age range of 21–61 years. Side-effects were minimal. Drowsiness was reported by two people in the placebo group, one taking chlorazepate dipotassium, three on prazepam and one on diazepam. One diazepam patient reported nausea and vomiting. Scores on the Zung Self-Rating Scale for Anxiety showed all three drug groups to be superior to placebo. The Hopkins Symptom Check-list found prazepam and diazepam to be superior to placebo and chlorazepate. No differences among the groups were found in the Hamilton Anxiety Scale. Prazepam may offer advantages over the other available benzodiazepines since it may be more readily absorbed than chlorazepate and has less side-effects than diazepam.


2021 ◽  
pp. 36-40
Author(s):  
A. L. Vertkin ◽  
A. N. Barinov ◽  
G. Yu. Knorring

Pain syndrome accompanies the vast majority of diseases; therefore, the issues of adequate pain relief remain topical not only for urgent conditions, but also for everyday medical practice. Modern and changed in recent years approaches to the appointment of anesthetic therapy should take into account not only the pathogenetic mechanisms of the development of pain syndrome in a particular patient, but also the need to use drug combinations. This allows for the potentiation of the analgesic effect, reduction of effective dosages of individual drugs and minimization of side effects. In case of severe pain syndrome in the presence of signs of impaired nociception, neuropathic and muscle-fascial pain syndromes, the use of non-steroidal anti-inflammatory drugs in conjunction with group B vitamins is justified. The article considers the pathogenetic details of such a combination therapy, reveals the mechanisms of the cooperative action of the proposed combination of drugs.


2010 ◽  
Vol 1 (3) ◽  
pp. 122-141 ◽  
Author(s):  
Harald Breivik ◽  
Tone Marte Ljosaa ◽  
Kristian Stengaard-Pedersen ◽  
Jan Persson ◽  
Hannu Aro ◽  
...  

AbstractObjectivePatients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain.MethodsA 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates.ResultsMost patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups.ConclusionsAlthough the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period.ImplicationsA low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.


BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023715 ◽  
Author(s):  
Cosme Gay-Escoda ◽  
Magdi Hanna ◽  
Antonio Montero ◽  
Thomas Dietrich ◽  
Stefano Milleri ◽  
...  

ObjectivesTo compare efficacy/safety of oral tramadol 75 mg/dexketoprofen 25 mg (TRAM/DKP) and TRAM 75 mg/paracetamol 650 mg (TRAM/paracetamol) in moderate to severe pain following surgical removal of impacted lower third molar.DesignMulticentre, randomised, double-blind, placebo-controlled, phase IIIb study.ParticipantsHealthy adult patients scheduled for surgical extraction of at least one fully/partially impacted lower third molar requiring bone manipulation. 654 patients were randomised and 653 were eligible for analysis.InterventionsSurgery was performed under local anaesthetic. No sedation was permitted. Patients rated pain intensity (PI) using an 11-Numerical Rating Scale (NRS) (0 no pain; 10 worst pain). Participants experiencing moderate/severe pain (≥4) within 4 hours of surgery were randomised (2:2:1 ratio) to a single oral dose of TRAM/DKP 75/25 mg, TRAM/paracetamol 75/650 mg or placebo.Main outcome measuresEfficacy was based patients’ electronic diaries. Analgesia and pain were recorded as follows: pain relief (PAR) on a 5-point Verbal Rating Scale (0=‘no relief’, 1=‘a little (perceptible) relief’, 2=‘some (meaningful) relief’, 3=‘lot of relief’, 4=‘complete relief’) at the predefined postdose time points t15 min, t30 min, t1 hour, t1.5 hour, t2 hour, t4 hour, t6 hour and t8 hour and PI on the 11-point NRS at t0 and at the same predefined postdose time points. Onset of analgesia documented using double stopwatch method over a 2-hour period. Primary endpoint was total pain relief over 6 hours (TOTPAR6). Rescue medication was available during the treatment period.ResultsTRAM/DKP was superior to TRAM/paracetamol and placebo at the primary endpoint TOTPAR6 (p<0.0001). Mean (SD) TOTPAR6 in the TRAM/DKP group was 13 (6.97), while those in the active control and placebo groups were 9.1 (7.65) and 1.9 (3.89), respectively. Superiority of TRAM/DKP over active comparator and placebo was observed at all secondary endpoints. Incidence of adverse events was comparable between active groups.ConclusionsTRAM/DKP (75/25 mg) is effective and superior to TRAM/paracetamol (75/650 mg) in relieving moderate to severe acute pain following surgical removal of impacted lower third molar, with a faster onset of action, greater and durable analgesia, together with a favourable safety profile.Trial registration numberEudraCT 2015-004152-22 and NCT02777970.


2020 ◽  
pp. 107815522097062
Author(s):  
Uğur Çelik ◽  
Ertuğrul H Aydemir ◽  
Burhan Engin ◽  
Muazzez Ç Oba ◽  
Mesut Yılmaz ◽  
...  

Introduction Novel anti-cancer drugs such as targeted cancer therapies and immune check-point inhibitors (ICIs) have adverse events, especially concerning the skin. The aim of this study is to report an overview of the commonly consulted dermatological side effects of ICIs and targeted cancer therapies in clinical practice, along with their management. Methods In this single-center study, we evaluated consecutive oncological patients who were referred from the oncology outpatient clinic to the dermatology outpatient clinic due to skin side effects of ICIs and targeted therapies. All patients were examined and treated at the same day of referral by experienced dermatologists. Patient characteristics, clinical findings, diagnostic workups and treatments were retrieved from outpatient records. Results Sixty three patients were enrolled. Most common diagnoses were lung carcinoma, melanoma and colon carcinoma. Fifty patients (79%) were using targeted therapies while 13 (21%) were using ICIs. Xerosis was the most common side effect (44%), followed by acneiform rash, paronychia, eczema and pruritus. Majority of the side effects were grade 2 and 3. Psoriasis was a common side effect of ICIs. One patient had a newly developed dysplastic nevus on vemurafenib treatment. Oncological treatment was not withheld in any of the patients. Conclusions This study revealed the most commonly consulted skin side effects of novel anti-cancer drugs and their management in daily practice. We underlie the importance of collaborative work of oncology and dermatology professionals as early management of cutaneous side effects of targeted therapies and ICIs improves patient outcomes.


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