Research/Practice
ausencia de precision en las medidas por tirilla de la saliva y el alto mimero de resultados falso negativo hacen de esta prueba una alternativa pobre para el uso en la determinacion de alcohol en pacientes de la sala de emergencia. WILMA M. GUZMAN
RESUME
La determination rapide des concentrations seriques d'ethanol peut s'averer utile lors d'evaluation de patients ou I'etat de conscience est diminue. Des etudes precedentes ont suggere que les concentrations salivaires d'ethanol mesurees avec un batonnet colorirnetrique etablissaient une bonne correlation avec Ie niveau serique d'ethanol et pourraient eventuellement etre utiles dans des situations d'urgence. Les auteurs ont compare les concentrations
salivaires aux concentrations seriques de 67 patients se presentant a l'urgence avec une diminution de leur etat de conscience. Les changements de couleur du batonnet etaient calibres pour refleter des concentrations seriques d'ethanol de 0, 20, 50, 100 et 300 mg/dl, ou plus. Le personnel de l'urgence a utilise les batonnets selon la methode suggeree par Ie fabricant et a arrondi les resultats equivoques a la concentration suivante la plus elevee. Parmi les resultats obtenus, il y a eu 12 faux negatifs et 2 faux positifs. La correlation entre les resultats obtenus avec Ie batonnet et ceux par mesure serique etait de rho: 0.611 soit un p' The intramuscular route obviates the need for an intravenous administration set and saves time, as well. We performed a comparative study using intramuscular diclofenac sodium vesus Baralgin, a combination drug composed of three active agents: dipyrone (a pyrazolic compound) 2.5 g, fenpipramide methobromide (a papaveric spasmolytic agent) 0.01 g, and pitofenone hydrochloride (an atropinic spasmolytic agent) 0.0001 g, in distilled water. Baralgin must be administered by slow intravenous infusion. Our objectives were to evaluate the clinical efficacy for analgesia and incidence of adverse effects when using diclofenac and Baralgin during the first hours of a renal colic episode.
Methods The present study was designed as a prospective, randomized, comparative, double-blind, controlled clinical trial, using the double-dummy technique. The protocol was accepted by the hospital's Ethical Committee and informed consent was obtained from the patients. Sixty-one
DICP, The Annals of Pharmacotherapy Downloaded from aop.sagepub.com at UNIV CALIFORNIA SAN DIEGO on January 24, 2016
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1990 April, Volume 24
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361
patients of both sexes, over the age of 18 years, were randomly distributed into two groups: the diclofenac group treated by intramuscular injection and the control group treated with Baralgin via slow intravenous infusion. Emergency room patients affected with clinically diagnosed renal colic and hematuria and/or a compatible image in abdominal X-ray, with a pain level ;0,2 as measured on the a1gometric descriptive scale,' were recruited to the study over a period of one year. The algometric descriptive scale classifies degree of pain as follows: 0 = no pain; I = slight pain, tolerable without medication; 2 = moderate pain, patient requests medication but is calm and unagitated; and 3 = intense pain, patient needs medication, is writhing, highly agitated, or seems to be in serious condition. Excluded from the trial were patients who were allergic to any of the components of Baralgin or diclofenac, those with fever or suspected of having pyelonephritis, those who had been administered analgesics within the previous six hours or had been in pain for 48 hours or more, pregnant and nursing women, and those with symptoms compatible with active peptic ulcer disease. Patients with signs of urinary tract infections and those whose initial diagnosis was changed were later excluded from the trial. A single dose of diclofenac 75 mg dissolved in 3 mL of NaCl 0.9% was administered to the diclofenac group as an im injection, along with a Baralgin placebo of 5 mL of NaCI 0.9% administered by slow iv infusion (4-5 min). Control patients were administered a single dose of Baralgin 5 mL by slow iv infusion (4-5 min), and a diclofenac placebo of 3 mL of NaCI 0.9% by im injection. In cases of pain persisting up to 30 minutes, or of relapse during the first or second hour after the first dose, a second dose of the first drug assigned to the subject was administered. If, 30 minutes after this second dose, there was no acceptable improvement, then morphine sulfate was administered. Relapse was defined as the reappearance of pain on a level ;0,2on the pain scale, and persistence as no improvement in pain classified by ;0,2on the same scale. The treatment efficacy criterion was measured by the evolution of the degree of pain observed at 15, 30, 60, and 120 minutes, as measured on a descriptive a1gometric scale.' All patients who experienced no or slight pain (0 or I on the pain scale) for a minimum of two hours were discharged. Tolerability was evaluated by the incidence of adverse effects observed in patients as well as by the variation in blood pressure readings taken before the treatment and 30 minutes afterwards. In all cases, complementary explorations were performed to detect microscopic hematuria and the presence or absence of stag-horn and/or ureteral calculi by Xray, and if indicated, abdominal sonogram and/or intravenous pyelography. Only two physicians participated in recording the evaluation of the pain's evolution, so as to avoid interobserver bias. Statistical analysis of the data was done using the SPSS-PC (Statistical Package for Social Sciences) program in an IBM PC XT. The differences among means were analyzed by the Student r-test for independent data. Differences in systolic and diastolic blood pressure for each individual, before and afterthe treatment, were compared between the two groups by the paired r-tests for bilateral tests. Frequency differences between the groups were analyzed by the chi-square test and the Yates correction factor was applied when the expected effects were below 5. The degree of significance accepted for a bilateral test was p
ausencia de precision en las medidas por tirilla de la saliva y el alto mimero de resultados falso negativo hacen de esta prueba una alternativa pobre para el uso en la determinacion de alcohol en pacientes de la sala de emergencia. WILMA M. GUZMAN
RESUME
La determination rapide des concentrations seriques d'ethanol peut s'averer utile lors d'evaluation de patients ou I'etat de conscience est diminue. Des etudes precedentes ont suggere que les concentrations salivaires d'ethanol mesurees avec un batonnet colorirnetrique etablissaient une bonne correlation avec Ie niveau serique d'ethanol et pourraient eventuellement etre utiles dans des situations d'urgence. Les auteurs ont compare les concentrations
salivaires aux concentrations seriques de 67 patients se presentant a l'urgence avec une diminution de leur etat de conscience. Les changements de couleur du batonnet etaient calibres pour refleter des concentrations seriques d'ethanol de 0, 20, 50, 100 et 300 mg/dl, ou plus. Le personnel de l'urgence a utilise les batonnets selon la methode suggeree par Ie fabricant et a arrondi les resultats equivoques a la concentration suivante la plus elevee. Parmi les resultats obtenus, il y a eu 12 faux negatifs et 2 faux positifs. La correlation entre les resultats obtenus avec Ie batonnet et ceux par mesure serique etait de rho: 0.611 soit un p' The intramuscular route obviates the need for an intravenous administration set and saves time, as well. We performed a comparative study using intramuscular diclofenac sodium vesus Baralgin, a combination drug composed of three active agents: dipyrone (a pyrazolic compound) 2.5 g, fenpipramide methobromide (a papaveric spasmolytic agent) 0.01 g, and pitofenone hydrochloride (an atropinic spasmolytic agent) 0.0001 g, in distilled water. Baralgin must be administered by slow intravenous infusion. Our objectives were to evaluate the clinical efficacy for analgesia and incidence of adverse effects when using diclofenac and Baralgin during the first hours of a renal colic episode.
Methods The present study was designed as a prospective, randomized, comparative, double-blind, controlled clinical trial, using the double-dummy technique. The protocol was accepted by the hospital's Ethical Committee and informed consent was obtained from the patients. Sixty-one
DICP, The Annals of Pharmacotherapy Downloaded from aop.sagepub.com at UNIV CALIFORNIA SAN DIEGO on January 24, 2016
•
1990 April, Volume 24
•
361
patients of both sexes, over the age of 18 years, were randomly distributed into two groups: the diclofenac group treated by intramuscular injection and the control group treated with Baralgin via slow intravenous infusion. Emergency room patients affected with clinically diagnosed renal colic and hematuria and/or a compatible image in abdominal X-ray, with a pain level ;0,2 as measured on the a1gometric descriptive scale,' were recruited to the study over a period of one year. The algometric descriptive scale classifies degree of pain as follows: 0 = no pain; I = slight pain, tolerable without medication; 2 = moderate pain, patient requests medication but is calm and unagitated; and 3 = intense pain, patient needs medication, is writhing, highly agitated, or seems to be in serious condition. Excluded from the trial were patients who were allergic to any of the components of Baralgin or diclofenac, those with fever or suspected of having pyelonephritis, those who had been administered analgesics within the previous six hours or had been in pain for 48 hours or more, pregnant and nursing women, and those with symptoms compatible with active peptic ulcer disease. Patients with signs of urinary tract infections and those whose initial diagnosis was changed were later excluded from the trial. A single dose of diclofenac 75 mg dissolved in 3 mL of NaCl 0.9% was administered to the diclofenac group as an im injection, along with a Baralgin placebo of 5 mL of NaCI 0.9% administered by slow iv infusion (4-5 min). Control patients were administered a single dose of Baralgin 5 mL by slow iv infusion (4-5 min), and a diclofenac placebo of 3 mL of NaCI 0.9% by im injection. In cases of pain persisting up to 30 minutes, or of relapse during the first or second hour after the first dose, a second dose of the first drug assigned to the subject was administered. If, 30 minutes after this second dose, there was no acceptable improvement, then morphine sulfate was administered. Relapse was defined as the reappearance of pain on a level ;0,2on the pain scale, and persistence as no improvement in pain classified by ;0,2on the same scale. The treatment efficacy criterion was measured by the evolution of the degree of pain observed at 15, 30, 60, and 120 minutes, as measured on a descriptive a1gometric scale.' All patients who experienced no or slight pain (0 or I on the pain scale) for a minimum of two hours were discharged. Tolerability was evaluated by the incidence of adverse effects observed in patients as well as by the variation in blood pressure readings taken before the treatment and 30 minutes afterwards. In all cases, complementary explorations were performed to detect microscopic hematuria and the presence or absence of stag-horn and/or ureteral calculi by Xray, and if indicated, abdominal sonogram and/or intravenous pyelography. Only two physicians participated in recording the evaluation of the pain's evolution, so as to avoid interobserver bias. Statistical analysis of the data was done using the SPSS-PC (Statistical Package for Social Sciences) program in an IBM PC XT. The differences among means were analyzed by the Student r-test for independent data. Differences in systolic and diastolic blood pressure for each individual, before and afterthe treatment, were compared between the two groups by the paired r-tests for bilateral tests. Frequency differences between the groups were analyzed by the chi-square test and the Yates correction factor was applied when the expected effects were below 5. The degree of significance accepted for a bilateral test was p
