A Multiple-Dose, Double-Blind Comparison of Intramuscularly and Orally Administered Ketorolac Tromethamine and Ketogan® in Patients with Pain following Orthopaedic Surgery

1994 ◽  
Vol 22 (4) ◽  
pp. 202-217 ◽  
Author(s):  
P H Gebuhr ◽  
M Soelberg ◽  
W Strauss

In this multiple-dose, double-blind study 100 patients with moderate, severe or very severe pain following orthopaedic surgery were randomly assigned to receive ketorolac, a nonsteroidal anti-inflammatory drug with potent analgesic properties (10 mg), or the standard regimen of Ketogan® (a combination product containing the narcotic analgesic, ketobemidone, plus a spasmolytic agent) by intramuscular injection every 1 – 6 h as needed for pain. When patients were able to tolerate an oral diet and were expected to respond to oral analgesic medication, based on overall pain sensitivity, they were switched to oral doses of the same medication every 4 – 6 h as needed. A maximum of four daily doses of medication was allowed for up to 10 days. The severity of pain was scored on a five-point scale and was recorded before the first intramuscular dose, at fixed time points therafter for up to 6 h and at the end of each day. Both treatments were effective immediately after the first dose and during the subsequent multiple-dose phase. There were no statistically significant differences between ketorolac and Ketogan®. The results show that 10-mg doses of ketorolac in intramuscular injections followed by 10-mg doses of oral ketorolac are as effective as Ketogan® for the treatment of pain following orthopaedic surgery. Ketorolac appears to be better tolerated than Ketogan® since significantly fewer patients reported adverse events ( P = 0.004) when taking ketorolac.

1982 ◽  
Vol 10 (6) ◽  
pp. 408-413 ◽  
Author(s):  
C E Parker ◽  
A F Langrick

In a double-blind study the analgesic efficacy and acceptability of meptazinol 200 mg was compared with placebo in patients suffering from acute or chronic pain. Patients were randomly allocated to receive either 200 mg of meptazinol or one tablet of placebo 4 to 6 hourly over a 14-day period. Clinical evaluations were made by the physician at baseline and again at the end of the study. The patients made daily recordings of pain using a visual analogue scale. The results showed that meptazinol was a more effective and acceptable analgesic than placebo. There was no significant difference in the incidence of adverse effects reported by patients in either treatment group.


1983 ◽  
Vol 11 (5) ◽  
pp. 308-314 ◽  
Author(s):  
Leo Winter ◽  
Arthur Post

The safety and efficacy of single oral doses of Oxaprozin (1200 mg), aspirin (650 mg), and placebo were compared in an 8-hour double-blind study of 105 patients with moderate to severe post-operative dental-surgical pain. As measured by mean and cumulative mean scores obtained with the pain intensity and verbal pain relief scales, both active drugs produced significantly (p < 0·05) more analgesia than did placebo. A significantly (p < 0·05) greater proportion of patients reported effective (moderate or better) pain relief in the Oxaprozin and aspirin groups than in the placebo group at 2, 3, and 4 hours; significant (p < 0·05) differences between the Oxaprozin and placebo groups continued for the entire 8 hours. Oxaprozin provided more pain relief than aspirin during the latter part of the study. There were no statistically significant differences, however, in any of the efficacy assessments between the Oxaprozin and aspirin groups. By the end of the 8-hour observation, significantly (p < 0·01) fewer patients taking Oxaprozin (27%) than placebo (60%) were considered treatment failures and needed a replacement analgesic. Of those taking aspirin, 41% were treatment failures, not statistically different from the proportion of treatment failures with placebo. Adverse effects were infrequent, mild, comparable between the active treatment and placebo groups, and not definitely related to drug therapy. Oxaprozin provided greater pain relief than placebo and was comparable to aspirin during the first 4 hours of the evaluation; thereafter, greater pain relief occurred in the oxaprozin-treated group than either the aspirin- or placebo-treated group.


1981 ◽  
Vol 9 (6) ◽  
pp. 478-481 ◽  
Author(s):  
Pierre Federspil ◽  
Peter Bamberg

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.


2017 ◽  
Vol 41 (S1) ◽  
pp. S415-S415
Author(s):  
A. Mowla

IntroductionUp to 50% of patients with OCD have failed to respond in SSRI trials, so looking for pharmacological alternatives in treatment of obsessive compulsive disorder (OCD) seems necessary.ObjectivesSurveying duloxetine augmentation in treatment of resistant OCD.AimsStudy the effects of serotonin-norepinephrine enhancers for treatment of OCD.MethodsThis augmentation trial was designed as an 8-week randomized controlled, double blind study. Forty-six patients suffering from OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor (fluoxetine, citalopram or fluvoxamine) were randomly allocated to receive duloxetine or sertraline plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure.ResultsForty-six patients (24 of 30 in duloxetine group and 22 of 27 in sertraline group) completed the trial. Both groups showed improvement over the 8-week study period (mean Y-BOCS total score at week 8 as compared with baseline: P < 0.001 and P < 0.001) without significant difference (P = 0.861). Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0% in Y-BOCS score and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5% in Y-BOCS.ConclusionsOur double blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in resistant OCD patients. However, it needs to be noted that our study is preliminary and larger double blind placebo controlled studies are necessary to confirm the results.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2002 ◽  
Vol 60 (3A) ◽  
pp. 537-541 ◽  
Author(s):  
Marcelo Eduardo Bigal ◽  
Carlos Alberto Bordini ◽  
José Geraldo Speciali

Acute headache is a very frequent symptom, responsible for a significant percentage of caseload at primary care units and emergency rooms. Chlorpromazine is easily available in such settings. The aim of this study is to conduct a randomized, placebo-controlled, double-blind study to assess the efficacy of chlorpromazine on the acute treatment of episodic tension-type headache. We randomized 30 patients to receive placebo (10 ml of saline intravenous injections) and 30 patients to receive 0.1 mg/Kg chlorpromazine intravenously. We used 7 parameters of analgesic evaluation. Patients receiving chlorpromazine showed a statistically significant improvement (p < 0.05 and p < 0.01) of pain compared to placebo, far up to 30 minutes after the drug administration. The therapeutic gain was 36.7% in 30 minutes and 56.6 % in 60 minutes. The number needed to treat (NNT, the reciprocal or the therapeutic gain) was 2.7 in 30 minutes and 1.8 in 60 minutes. There were reductions in the recurrence and in the use of rescue medication in the chlorpromazine group. We can conclude that intravenous chlorpromazine is an effective drug to relief the pain in tension-type headache.


1997 ◽  
Vol 25 (4) ◽  
pp. 175-181 ◽  
Author(s):  
H Al-Muhaimeed

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.


1990 ◽  
Vol 8 (6) ◽  
pp. 1063-1069 ◽  
Author(s):  
J Bonneterre ◽  
B Chevallier ◽  
R Metz ◽  
P Fargeot ◽  
E Pujade-Lauraine ◽  
...  

Seventy-five breast cancer patients scheduled to receive a first course (in a new cycle) of cyclophosphamide, fluorouracil, and doxorubicin (FAC) or epirubicin (FEC) participated in a double-blind crossover study to compare the antiemetic efficacy and safety of ondansetron (GR38032), a 5-hydroxytryptamine3 (5-HT3) receptor antagonist, and metoclopramide. Ondansetron was given as an 8 mg loading dose (4 mg intravenously [IV] plus 4 mg orally) before chemotherapy followed by 8 mg every 8 hours orally for 3 to 5 days. Metoclopramide was given as an 80 mg loading dose (60 mg IV plus 20 mg orally) before chemotherapy followed by 20 mg every 8 hours orally for 3 to 5 days. A "period" interaction in the analysis of emetic response in the first 24 hours necessitated a parallel group analysis of first treatments only, 68 patients being assessable for this parameter. In the first 24 hours, complete or major control (zero to two emetic episodes) of emesis was achieved in 30 of 35 (86%) patients receiving ondansetron and in 14 of 33 (42%) patients receiving metoclopramide (P less than .001). Ondansetron was also more effective in reducing acute nausea. On days 2 to 3, the complete or major responses were significantly better with ondansetron (81% v 65%; P = .033), but there was no statistical difference in the control of nausea. There was a significant patient preference for ondansetron (63% v 26%; P = .001). Extrapyramidal reactions were observed in two metoclopramide treatments; both treatments were otherwise well tolerated. These results are consistent with serotonin (5-HT), being a significant neurotransmitter of cyclophosphamide/doxorubicin- or epirubicin/fluorouracil-induced emesis.


1995 ◽  
Vol 23 (4) ◽  
pp. 438-443 ◽  
Author(s):  
A. Davis ◽  
S. Krige ◽  
D. Moyes

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 μg/kg (Group A), ondansetron 75 μg/kg (Group B), or droperidol 75 fig/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 μg/kg was as effective as 150 μg/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.


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