Double-Blind Comparison of Single Oral Doses of Oxaprozin, Aspirin, and Placebo for Relief of Post-Operative Oral Surgery Pain

1983 ◽  
Vol 11 (5) ◽  
pp. 308-314 ◽  
Author(s):  
Leo Winter ◽  
Arthur Post
Keyword(s):  
Placebo Group ◽  
Pain Relief ◽  
Oral Surgery ◽  
Treated Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Surgical Pain ◽  
Blind Comparison ◽  
Oral Doses

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.

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
Keyword(s):  
Orthopaedic Surgery ◽  
Multiple Dose ◽  
Fixed Time ◽  
Double Blind Study ◽  
Standard Regimen ◽  
Double Blind ◽  
Intramuscular Dose ◽  
Blind Comparison ◽  
Oral Doses ◽  
To Receive

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.

Diclofenac Sodium in Ureteral Colic: A Double-Blind Comparison Trial with Placebo

1983 ◽  
Vol 11 (5) ◽  
pp. 303-307 ◽  
Author(s):  
A Vignoni ◽  
A Fierro ◽  
G Moreschini ◽  
M Cau ◽  
A Agostino ◽  
...  
Keyword(s):  
Placebo Group ◽  
Saline Solution ◽  
Diclofenac Sodium ◽  
Complete Relief ◽  
Double Blind Study ◽  
Prostaglandin Synthetase ◽  
Double Blind ◽  
Ureteral Colic ◽  
Comparison Trial ◽  
Blind Comparison

A randomized prospective double-blind study of the analgesic effect of 75 mg intramuscular diclofenac sodium (Voltaren®), a potent prostaglandin synthetase inhibitor, versus placebo (saline solution) was carried out in 131 consecutive patients with acute ureteral colic. Diclofenac provided complete relief of pain 25 minutes after the injection in 59% of the cases, while placebo provided relief in 29% (p < 0·01). Forty patients in the placebo group and seventeen patients in the diclofenac group needed an open injection of 75 mg diclofenac intramuscularly after 25 minutes due to persistent pain. Fifty-four of the fifty-seven patients treated with an open injection of diclofenac achieved complete relief of pain after 30 minutes. There were no side-effects of the treatment.

EFFECT OF ANTIAGGREGANT ON OCCLUSION OF SAPHENOUS GRAFT CORONARY BYPASS

1987 ◽  
Author(s):  
E Lavenne-Pardonge ◽  
C Col-De Beys ◽  
R Dion ◽  
R Ponlot ◽  
M Moriau
Keyword(s):  
Placebo Group ◽  
Coronary Bypass ◽  
Arterial Disease ◽  
Treated Group ◽  
Double Blind Study ◽  
Careful Study ◽  
Double Blind ◽  
Normal Limits ◽  
Group 2 ◽  
Long Acting

Double blind study on 49 patients, 24receiving aspirine-dipyri-damole, 25 a placebo. In both groups 20 patients were followed during one year. The two groupsdid not differ according to age, sex and number of coronary bypass. In all the patients, Calparin (3 x 5000 U/day) was injected subcutanously the day before andthe 7 days after surgery. In the first group dipyridamole (25 mg/ kg) was injected during the same period. The second group received a placebo IV injection. Thereafter long acting dipyridamole (400 mg/day) and aspirin (200 mg/day) were given orally in the first group, placebo in the second one. Cardiac follow-up included E.C.G. and thallium at maximum exercise. Coronarography was performed only incase of reappearence of chest pain. No difference was found between the two groups for the coagulation parameters duringthe whole year of study. Statistically significant differences between the two groups were found during the same period for β-thromboglobulin, fibrino-peptide A and the ratio Δ+ βTG/Δ+ FPA. Plateletactivity, elevated in the placebo group, was kept in normal limits in the treated group. During the two first months for the placebo and during the first month for the treated group the ratio Δ+ βTG/Δ+ FPA decreased in all patients showing the importance at this time of plasmatic hypercoagulability compared to platelet hyperactivity. During the 12 months of the study 5 thrombotic accidents (25 %) were noted in the placebo group (2 myocardial infarctions, 2 occlusions of bypass, 1 case of cerebral arterial disease) and 2 (10 % in the treated group) (1 postoperative death, 1 myocardial infarction) (NS ; p =0,21). Our results lead to two conclusions : 1) Platelet antiaggregants may influencethe permeability of saphenous .graft coronary bypass. A careful study of platelet acti-r vity with eventual change of the drug used may improve the late resultsof surgery. 2) Association of anticoagulant therapy (anti-vitamin K) during the two first months after surgery could also be useful.

scholarly journals Paranasal sinus air suction for immediate pain relief of acute migraine – a randomized, double blind pilot study

BMC Neurology ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
S. M. R. Bandara ◽  
S. Samita ◽  
A. M. Kiridana ◽  
D. M. P. U. K. Ralapanawa ◽  
H. M. M. T. B. Herath
Keyword(s):  
Pain Relief ◽  
Paranasal Sinus ◽  
Rating Scale ◽  
International Headache Society ◽  
Treated Group ◽  
Control Group ◽  
Double Blind Study ◽  
Airflow Rate ◽  
Acute Migraine ◽  
Double Blind

Abstract Background Migraine is a primary headache disorder, which cause significant disability in adolescence. This double blind, randomized clinical trial assessed the immediate effects of suction of paranasal sinus air during an acute migraine episode. Methods A randomized, double blind study was conducted with 56 selected Sri Lankan school children of 16–19 years of age. Participants who met International Headache Society criteria for migraine (with or without aura) were included in the study. Subjects were randomly allocated into 2 groups where one group was subjected to three intermittent 10 sec paranasal air suctions with a ten sec suction free interval between two suctions for each nostril and the other group was subjected to placebo air suction (no paranasal air suction) in similar arrangement. Severity of headache and sub–orbital tenderness before and after suction were recorded using standard pain rating scale. Results After dropouts, treated and placebo groups consisted of 27 and 23 subjects respectively. The mean headache pain score drop in the treated group was significantly higher compared to that of the control group. Moreover, there was a difference in the treatment response between the types of headache (with or without aura). With respect to tenderness there was a statistically significant drop in the treated group compared to the control. In general, airflow rates in left and right nostrils were different in these subjects. However such difference was not seen in the tenderness on two sides. Nevertheless it was revealed that airflow rate has a slight negative correlation with the tenderness irrespective of the side. Conclusion Sixty–second paranasal air suction can provide an immediate pain relief for acute migraine in adolescents. We did not assess pain outcomes beyond 60 s, but the initial responses suggests the need to further study the efficacy of paranasal suction in migraine. A further study is suggested to evaluate the acute effects, efficacy and side effects of paranasal air suction using follow up over a prolong period. Trial registration Sri Lanka Clinical Trials Registry SLCTR/2017/018, 29 Jun 2017. Retrospectively registered.

The Effect of Silicol Gel Compared with Placebo on Papulopustular Acne and Sebum Production. A Double-Blind Study

1996 ◽  
Vol 24 (4) ◽  
pp. 340-344 ◽  
Author(s):  
A Lassus
Keyword(s):  
Placebo Group ◽  
Treated Group ◽  
Double Blind Study ◽  
Concomitant Treatment ◽  
Double Blind ◽  
Area 5 ◽  
Significant Difference ◽  
The Face ◽  
Sebum Production ◽  
The Mean

Altogether 30 patients (19 females and 11 males), mean age 19 years, were divided randomly into two groups. All patients had chronic papulopustular acne of the face. A total of 15 patients were treated topically with Silicol gel for 20 min twice daily for 6 weeks and the remaining 15 patients were treated with a placebo gel in a similar fashion. A clinical evaluation was carried out at baseline, and after 2, 4 and 6 weeks of treatment. The clinical variables evaluated were as follows: number of comedones, papules, pustules and cysts on a standard area of the left cheek (area 5 × 5 cm) and measurement of sebum production on the same area by the use of Sebumeter SM 810 PC (Courage and Khazaka, Ltd, Germany). No concomitant treatment was allowed during the study period. One patient using Silicol gel withdrew after 2 weeks of treatment because of severe irritation of the facial skin, leaving 29 patients who could be evaluated. In the active group, the number of comedones decreased from a mean of 48.5 to 15.1 after 6 weeks of treatment. The corresponding figures for papules were 10.7 and 1.0, for pustules 6.8 and 0, and for cysts 0.6 and 0. In the placebo group no improvement could be observed. There was a highly significant difference in efficacy between the two groups ( P < 0.001) in favour of the actively treated group. The mean sebum index was 193 at baseline and 88 after 6 weeks. Correspondingly, in the placebo group the mean sebum index at baseline was 187 and after 6 weeks 179. This difference between the two groups was also statistically significant ( P < 0.001). After a short follow-up period (3 months) no deterioration was observed in the 14 ‘active’ patients, showing either complete cure or improvement.

scholarly journals Ondansetron for Prevention of Postoperative Nausea and Vomiting following Minor Oral Surgery: A Double-blind Randomized Study

1994 ◽  
Vol 22 (5) ◽  
pp. 576-579 ◽  
Author(s):  
M. R. C. Rodrigo ◽  
R. C. H. Campbell ◽  
J. Chow ◽  
C. K. A. Tong ◽  
E. Hui ◽  
...  
Keyword(s):  
Placebo Group ◽  
Postoperative Nausea ◽  
Oral Surgery ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
General Anaesthetic ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Minor Oral Surgery

The efficacy and safety of ondansetron in preventing postoperative nausea and vomiting following minor oral surgery was evaluated in a prospective randomized double-blind study. Of a total of seventy-seven patients, randomly 38 had 4 mg of ondansetron and 39 had normal saline as placebo intravenously immediately prior to induction of anaesthesia. A standard general anaesthetic with thiopentone, suxamethonium, fentanyl, nitrous oxide and isoflurane was employed. Postoperatively nausea was assessed verbally and on a visual analog scale at 1, 4 and 24 hours from the time of awakening. Episodes of vomiting were recorded. Eight patients (21.1%) in the ondansetron group compared to 19 (48.7%) in the placebo group had nausea (P < 0.05) and 1 (2.6%) in the ondansetron group compared with 9 (23.1%) in the placebo group vomited (P < 0.05). Patients who vomited twice or more and the number who required a rescue antiemetic were significantly fewer in the ondansetron group (P < 0.05). Cardiovascular parameters were stable and showed no significant difference in the two groups. There were no significant adverse effects that could be directly attributable to ondansetron.

Analgesic Combinations with Orphenadrine in Oral Post-Surgical Pain

1979 ◽  
Vol 7 (3) ◽  
pp. 240-246 ◽  
Author(s):  
Leo Winter ◽  
Arthur Post
Keyword(s):  
Pain Relief ◽  
Pain Intensity ◽  
Analgesic Efficacy ◽  
Intensity Difference ◽  
Double Blind Study ◽  
Oral Surgical Procedures ◽  
Double Blind ◽  
Pain Intensity Difference ◽  
Surgical Pain ◽  
Study Techniques

Two hundred male and female patients underwent a variety of oral surgical procedures and were treated qfterwards in four test groups. They took a combination of orphenadrine (25 mg) and acetaminophen (325 mg), either drug alone, or placebo. A double-blind study design was used. All patients had moderately severe baseline pain intensity; post-treatment pain relief was recorded at 30 minutes, one, two, four and six hours. A back-up analgesic (codeine-ASA) was made available if needed. Pain intensity difference (PID) and sums of pain intensity difference (SPID) were calculated using established analgesic study techniques. Statistical analyses indicated better analgesic efficacy in both PID and SPID scores for the orphenadrine-acetaminophen combination over the three other treatments. This was evident at 30 minutes and continued through the sixth hour. Each active drug, in turn, was also significantly better throughout than placebo for pain relief. Sub-groups in each treatment regimen required additional pain relief prior to six hours, with significantly more placebo than orphenadrine-acetaminophen patients needing remedication. Side-effect incidence was very low and randomly distributed among the four groups-

The Effect of Warfarin Sodium on the Duration of Platelet Aggregation

1967 ◽  
Vol 18 (03/04) ◽  
pp. 766-778 ◽  
Author(s):  
H. J Knieriem ◽  
A. B Chandler
Keyword(s):  
Platelet Count ◽  
Placebo Group ◽  
Platelet Aggregation ◽  
Prothrombin Time ◽  
Platelet Rich Plasma ◽  
Healthy Adults ◽  
Double Blind Study ◽  
Double Blind ◽  
Warfarin Sodium

SummaryThe effect of the administration of warfarin sodium (Coumadin®) on the duration of platelet aggregation in vitro was studied. Coumadin was given for 4 consecutive days to 10 healthy adults who were followed over a period of 9 days. The duration of adenosine diphosphate-induced platelet aggregation in platelet-rich plasma, the prothrombin time, and the platelet count of platelet-rich plasma were measured. Four other healthy adults received placebos and participated in a double-blind study with those receiving Coumadin.Although administration of Coumadin caused a prolongation of the prothrombin time to 2 or 21/2 times the normal value, a decrease in the duration of platelet aggregation was not observed. In most individuals who received Coumadin an increase in the duration of platelet aggregation occurred. The effect of Coumadin on platelet aggregation was not consistently related to the prothrombin time or to the platelet count. In the placebo group there was a distinct relation between the duration of platelet aggregation and the platelet count in platelet-rich plasma.The mean increase in the duration of platelet aggregation when compared to the control value before medication with Coumadin was 37.7%. In the placebo group there was a mean increase of 8.4%. The difference between the two groups is significant (p <0.001). Increased duration of platelet aggregation also occurred in two individuals who received Coumadin over a period of 10 and 16 days respectively.

Sulphadiazine/Trimethoprim Once Daily in Maxillary Sinusitis: A Randomized Double-Blind Comparison with Sulphamethoxazole/Trimethoprim B.I.D.

1981 ◽  
Vol 9 (6) ◽  
pp. 478-481 ◽  
Author(s):  
Pierre Federspil ◽  
Peter Bamberg
Keyword(s):  
Maxillary Sinusitis ◽  
Favourable Result ◽  
Double Blind Study ◽  
Double Blind ◽  
Once Daily ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Blind Comparison ◽  
Cure Rates

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.

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