COMPARISON OF ANALGESIC EFFECT BETWEEN
DICLOFENAC SODIUM, KETOPROFEN, ALVERINE AND
HYOSCINE N-BUTYLBROMIDE IN RENAL AND
URETERAL COLIC: A PROSPECTIVE DOUBLE-BLIND STUDY.
Hisham S. Abou-Auda*1, Sabah M. Al-Rayes2,
Adel M. Yousef3, Rafiq R. Abou-Shaaban4,
Abdelmoniem Koko3 and Tawfeeg A. Najjar1
1. Department of Clinical Pharmacy,
College of Pharmacy, King Saud University,
P.O.Box 2457, Riyadh-11451, Saudi Arabia.
Tel. 467-7470
Fax 467-6229
E-mail: hisham@ksu.edu.sa
2.
Ministry of Health, Riyadh, Saudi Arabia.
3.
Department of Urology, Riyadh Central Hospital,
P.O.Box 2897, Riyadh-11196, Saudi Arabia.
4. College of Pharmacy, Ajman University for Science
and Technology, Abu Dhabi Campus, UAE
*
To whom correspondence should be addressed
Key Words: Renal colic, Ureteral colic, Diclofenac sodium, Ketoprofen, Alverine,
Hyoscine N-butylbromide, Saudi Arabia.
Abstract
Objective: To compare the analgesic effects of diclofenac sodium (DS) 75 mg IM,
ketoprofen (KET)100 mg IM, alverine (ALV) 40 mg IM or IV and hyoscine Nbutylbromide (HBB)20 or 40 mg IM or IV.
Design: randomized, double-blind, prospective study.
Setting: the emergency department in Riyadh Central Hospital, Saudi Arabia.
Patients: 444 patients (372 males and 72 females), 14-70 years of age, with moderate to
severe pain due to renal or ureteral colic.
Interventions: Subjects received a single dose of one of the test medications and patients
valuated their pain intensity and pain relief at 0 (baseline), 15, 30, 45 minutes and hourly
for 3 hours. If no improvement after 15 min, a second dose of the same medication is
administered.
Results: Significant differences (p<0.05) were found between the four groups with
respect to pain intensity difference (PID), mean pain relief and onset time of analgesia.
Diclofenac sodium and ketoprofen were equally effective, and both were significantly
(p<0.05) superior to alverine and hyoscine N-butylbromide in pain relief. Significantly
(p<0.5) fewer patients required a second dose in either diclofenac sodium or ketoprofentreated groups compared to the other two spasmolytic groups. The dose and the route of
administration of hyoscine N-butylbromide and the route of administration of alverine
had no significant (p>0.05) effect on the proportion of patients with complete relief.
Conclusions: diclofenac sodium and ketoprofen can be safely used in the management
of acute renal and ureteral colic as an alternative to spasmolytic agents.
2
Introduction
The pain of ureteral and renal colic is a result of an acute upper urinary tract
obstruction leading to distention and an increase in tension within the walls of the ureter
and renal pelvis (1-2). It is suggested that prostaglandins play an important role in the
pathogenesis of ureteral and renal colic by stimulating secretion in the kidney, thus
raising the pressure in the renal tract above the ureteric obstruction (3-4). Inflammatory
edema is further increased by prostaglandins, namely PGE2, around the stone which
again increase the tension on the renal pelvic wall.
Analgesics are commonly employed in combination with spasmolytic drugs for
the treatment of renal and ureteral colic. The involvement of prostaglandins promoted
clinical experimentation to investigate the effectiveness of non-steroidal antiinflammatory drugs (NSAID) in alleviating the pain of renal and ureteral colic. These
drugs block the enzyme cyclo-oxygenase and hence, inhibit prostaglandins formation.
Several studies demonstrated that NSAID's such as diclofenac sodium (75 mg
intramuscularly) is more effective than pethidine (100 mg intramuscularly) (5-6), other
narcotic analgesics (7), spasmolytic agents (fenpipramide methbromide and pitofenone
hydrochloride) (8), pyrazolone-derived analgesics (e.g., dipyrone)(8-9), or placebo (1012) in the treatment of renal or ureteral colic. Ketoprofen, a phenylpropionic acid
derivative similar to ibuprofen, has never been compared with diclofenac sodium or
spasmolytics in this respect. Recently, the mode of action of ketoprofen, as with other
NSAID's, was shown to be the inhibition of prostaglandin synthesis, which is also
considered to be responsible for pain in renal colic (13). Intravenous administration of
ketoprofen (200 mg) has been reported to be effective in the treatment of pain due to
renal colic compared with lysine acetylsalicylates (1 g IV) (14). Although the efficacy of
3
spasmolytic agents in renal and ureteral colic has been debated, they are widely used
alone or in combination with narcotic analgesics in many countries including Saudi
Arabia and other Arabian gulf countries. In a renal colic study, a single 20-mg
intravenous dose of hyoscine N-butylbromide (Buscopan) demonstrated that this
spasmolytic agent has a low analgesic effect when it is used as single therapy or with a
2.5-gm dose of dipyrone (15). Alverine, a musculotropic antispasmodic similar to
papaverine, has a direct action unrelated to muscle innervation. It behaves like an
antagonist of calcium at the cellular membrane level and raises 3’5’ AMP by inhibition
of phosphodiesterases. Although it is mainly used in the treatment of irrirable bowel
syndrome, alverine was one of the most widely used drugs for renal and ureteral colic in
Saudi Arabia and some European countries.
The aim of our study was to compare the therapeutic efficacy, safety and
tolerability of two NSAID's, namely, diclofenac sodium and ketoprofen, and two
spasmolytic drugs, namely, alverine and hyoscine N-butylbromide in the treatment of
renal and ureteral colic. Due to intense pain involved with renal colic, the use of a
control group (placebo) was disregarded. Most of the reported studies were conducted
with a small sample size. This study emphasizes the use of a large patient population of
both sexes to ensure statistical reproducibility allowing to draw meaningful conclusions.
Materials and Methods
Patients:
A randomized, single-center and prospective double-blind design was used. Patients
with moderate to severe renal or ureteral colic admitted to emergency room (ER) at
Riyadh Central Hospital were recruited to the study. Patients with documented evidence
4
of previous episodes owing to calculi or execretory urographic results substantiating this
diagnosis were also included in the study.
Patients with another severe concomitant disorders, or with a history of renal
malfunction, cardiac failure, bronchial asthma, dyspepsia, peptic ulceration or hepatic
disorder, or those with documented allergy to any of the study medications, or those who
received any analgesic within 6 hours before the study were excluded. Pregnant or
breast-feeding women and those who were younger than 14 or older than 70 years were
also excluded from the study.
Four-hundred Forty four patients (372 males and 72 females) were included.
Each patient underwent a comprehensive examination including a complete medical
history, urinalysis (RBC, crystals and pus), and X-ray. The nature of the study was
explained fully to each participant and informed consent was obtained. A permission to
conduct the study was obtained from the research committee at Riyadh Central Hospital.
Patients were randomly assigned to one of 4 treatment groups: (1) Diclofenac
sodium (DS) (75 mg intramuscularly), (2) ketoprofen (KET) (100 mg intramuscularly),
(3) alverine (ALV) (40 mg intramuscularly or intravenously) and (4) Hyoscine Nbutylbromide (HBB) (20 or 40 mg intramuscularly or intravenously). Alverine was
given by slow intravenous push in 30 patients and intramuscularly in 58 patients. On the
other hand, hyoscine N-butylbromide was given intravenously in 62 patients and
intramuscularly in 47 patients. The route of administration for both drugs as well as the
dose of hyoscine N-butylbromide were determined randomly by the investigator.
Type of pain was also evaluated by the investigator as: acute (1), subacute (2) or
chronic (3). Pain intensity was evaluated verbally by each patient just before receiving
medication (baseline control) and at 15, 30 and 45 minutes. Patients were asked to
evaluate pain intensity as: no pain (0), mild (1), moderate (2) or severe pain(3).
5
Furthermore, patients were also asked to evaluate pain intensity at the designated
intervals using a visual analog scale (VAS) consisting of a 100-mm line whose ends
represented no pain (0 mm, pale pink) and very severe pain (100 mm, red). Pain relief
was also evaluated by patients using a four-point self-reported verbal rating scale (VRS)
as: no relief (0), mild relief (1), moderate relief (2) or complete relief (3). A second dose
of the same test medication was usually given if the pain intensity was not improved
after 15 minutes or if pain had returned. If pain persisted for another 15 minutes, a dose
of the other test drugs (from different group) was considered, i.e.; if the first drug was a
NSAID, the replacement drug should be a spasmolytic. Whenever significant pain relief
was not observed within 45 minutes, a standard analgesic, pentazocine, was given.
Those patients with moderate or complete pain relief after the first or second dose were
continued to be monitored at 15, 30, and 45 minutes and hourly for 3 hours. Figure 1
shows the study protocol. Throughout the period of the study, efforts were made to
maintain double-blind conditions and random selection of replacement drug(s). The
onset of action (the time required to reduce pain intensity score to "mild") for each dose
of the test medication was reported in minutes.
Pain relief (%) (Analgesic Efficacy) for each patient was calculated using the
following formula:
%R 
100 (I o  I t )
Io
equation 1
where, I o is the baseline pain intensity score before administering the test medication,
and It is the pain intensity score after 15 minutes from drug administration. Pain
intensity difference (PID) was defined as the baseline pain intensity minus the observed
pain intensity. Furthermore, patients were asked at each assessment interval to describe
any side effect. Patients were also asked to give an estimate of the onset of complete
6
analgesia in minutes. For patients who had no pain relief for more than 3 hours, a score
of 240 minutes (4 hours) was assigned.
Statistical Analyses:
Statistical analysis of data was performed using SPSS for Windows© (Statistical
Package for Social Sciences) program (version 10.0.7, SPSS Inc., USA). Homogeneity
of test groups was determined using repeated measures analysis of variance (ANOVA)
for continuous data, and chi-square with and/or without Yates' correction for continuity
and Kruskal-Wallis tests for discrete data.
To avoid interobserver variability, a limited number of physicians participated in
determining pain intensity and type of pain. Therapeutic efficacy was assessed by
analyzing the onset of analgesia by the analysis of variance with a factorial design. Pain
relief was compared for the four test groups using Kruskal-Wallis analysis of variance.
Chi-square test was also performed to test the effect of sex, concomitant disease, initial
pain intensity, type of pain, stone availability and history of pain on the observed results.
In few cases, Mann-Whitney “U” test was used to compare each pair of test medications
with respect to pain intensity difference (PID), while the Kruskal-Wallis test was
performed to confirm the results of PID for the four treatment groups.
Results
Four-hundred forty four patients, 372 males and 72 females, ranging in age from
14 to 70 years (mean  SD; 34.04  9.46 years) and in weight from 34 to 172 kg (mean 
SD; 68.52  15.23 kg) were included in the study. Of those patients, 111 received
diclofenac sodium, 113 received ketoprofen, 110 received alverine and 110 were given
hyoscine N-butylbromide. Baseline pain intensity scores were either 2 (moderate) or 3
7
(severe) for all patients and were comparable among the four treatment groups, with
mean value of 2.6, 2.5, 2.6 and 2.4 for DS, KET, ALV and HBB groups, respectively.
There were no statistically significant differences (p>0.05) in the demographic
characteristics of baseline pain assessment of patients in the four treatment groups. Table
1 summarizes patients' demographic data and the results of homogeneity of test groups.
No significant differences (p>0.05) were found to exist between the four treatment
groups with respect to age , sex, weight, type of pain, the presence of other diseases or
associated signs and symptoms, urinalysis, stone availability, pain evolution time before
treatment (pain intensity) or the site of pain. Complete pain relief was achieved in 100
of 111 patients (90.1 %) who received diclofenac sodium, 95 of 113 patients (84.1 %)
who received ketoprofen, 59 of 110 patients (53.6 %) who received alverine and 52 of
110 patients (47.3 %) who received hyoscine N-butylbromide as the first injection.
Worse pain or no change in pain intensity was observed in 51.8 %, 44.6 %, 11.5 % and
3.6 % of patients on hyoscine N-butylbromide, alverine, ketoprofen and diclofenac
sodium, respectively.
Mean pain relief scores derived from equation 1, for diclofenac sodium or
ketoprofen were significantly (p<0.05) higher than those observed for alverine and
hyoscine N-butylbromide. Figure 2 shows a plot of pain intensity difference (PID) for
each treatment group. The mean scores for diclofenac sodium and ketoprofen were
significantly (p<0.05) superior to those for alverine or hyoscine N-butylbromide at 10,
30, 45 minutes, 1 and 2 hours.
Patients who had worse pain, no change or moderate relief were given a second
dose of their assigned medication. Thus 59 patients required a second dose; 5 (4.4 %), 28
(25.5 %) and 26 (23.6 %) of those patients were on ketoprofen, alverine and hyoscine Nbutylbromide, respectively. Of those who required a second dose of hyoscine N-
8
butylbromide, 14 patients were given a 20-mg dose and 14 patients were given 40-mg
dose. No patients of the diclofenac sodium group required a second dose of the drug.
None of the patients who had a second dose of ketoprofen required an alternative drug
from the other group. Four patients needed an alternative drug after receiving a second
dose of alverine (2 ketoprofen and 2 diclofenac sodium), while 9 patients on hyoscine Nbutylbromide received an alternative drug from the other group (7 diclofenac sodium and
2 ketoprofen). Table 3 shows pain relief before and after the second dose. The mean
onset time of analgesia ranged from 38.7 min for diclofenac sodium, 40.2 min for
ketoprofen, 44.4 min for hyoscine N-butylbromide, to 49 min for alverine. No
statistically significant differences (p>0.05) were found to exist between the four
treatment groups with respect to the onset of analgesia after the administration of the
first dose. Insignificant pain relief or insufficient response to treatment was observed in
9 patients after 45 minutes; 3 in the ketoprofen-treated group and 3 in each of the two
spasmolytic-treated groups. Pentazocine, a standard analgesic with a known efficacy,
was given to these patients. Evaluation of pain intensity by patients using the visual
analog scale (VAS) linearly correlated (r=0.88) with pain assessment by clinicians using
the discrete pain intensity scale.
The route of administration of alverine and hyoscine N-butylbromide had no
effect on the outcome of the treatment (p>0.05) as shown in table 4. Moreover, the dose
of hyoscine N-butylbromide recommended by the manufacturer (20 mg IV) is said to be
inadequate. We found no statistically significant difference (p>0.05) between the 20-mg
and 40-mg doses of hyoscine N-butylbromide in terms of improvement of pain intensity
(Table 5). Pain at venipuncture site was observed to be statistically (p<0.05) more
frequent in the two spasmolytic groups compared with the NSAID groups. Type of pain
has no effect (p>0.05) on pain relief in the four treatment groups.
9
Tolerability of the drugs was demonstrated by the absence of relevant side
effects. One patient from each group experienced some kind of notable side effects.
Discussion
This study reveals that diclofenac sodium and ketoprofen can be used
successfully in the treatment of renal and ureteral colic. They are superior to the
spasmolytic agents used in this study. In most cases, a single dose of NSAID's produced
rapid and effective pain relief and was practically devoid of significant side effects.
Diclofenac sodium and ketoprofen are equally effective in terms of improvement
of pain intensity and the proportion of patients obtained complete relief of pain at 15
min. In addition to the anti-inflammatory and analgesic effects, like other NSAID's, a
central action has been considered for ketoprofen (16). Our results demonstrated that
NSAID's provide a faster and greater pain relief as indicated by the larger PID scores at
10, 30 and 45 minutes and by the smaller mean onset time for diclofenac sodium and
ketoprofen.
The results of spasmolytic treatment are usually inconsistent and transient and
require high doses which result in significant side effect (17-18). However, larger doses
of hyoscine N-butylbromide did not achieve a statistically significant (p>0.05)
improvement in pain relief compared with the dose recommended by the manufacturer.
Moreover, significantly (p<0.05) fewer patients required a second dose in either the
diclofenac sodium or ketoprofen-treated groups than in the alverine and hyoscine Nbutylbromide-treated groups.
In conclusion, this study demonstrated that the administration of NSAID's,
especially diclofenac sodium and ketoprofen, could offer clinicians another option for
10
renal and ureteral colic pain management as an alternative to the relatively less effective
spasmolytic drugs.
11
References
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2. Holmlund D. Ureteral stones. An experimental and clinical study of the mechanism
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Med Res 1983; 11:303-7.
11. Lundstam S, Wahlander L, Karl JG. Treatment of ureteral colic by prostaglandin
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nephretique [Voltaren in acute renal colic]. Gaz Med Fr 1981; 88:5557-8.
13. Kubota T, Komatsu H, Kawamoto H, Yamada T. Studies on the effects of antiinflammatory action of benzoyl- hydrotropic acid (ketoprofen) and other drugs, with
special reference to prostaglandin synthesis. Archives Internationale de
Pharmacodynamie et de Therapie 1979; 237: 169-176.
12
14. Magrini M, Pavesi G, Liverta C, et al. Intravenous ketoprofen in renal colic: a
placebo-controlled pilot study. Clin Ther 1984; 6:483-7.
15. Lloret J, Munoz J, Monmany J, Puig X, Bonastre M, Brau J, Sola J, Domingo P,
Jane F. Treatment of renal colic with dipyrone. Curr Ther Res 1987; 42:1119-26.
16. Debruyne D, De Ligny B, Ryckelynck J, Albessard F, Moulin M. Clinical
pharmacokinetics of ketoprofen after single intravenous administration as a bolus or
infusion. Clin Pharmacokin 1987; 12:214-21.
17. Anonymous. Anticholinergics/Antispasmodics. USP DI, Drug Information for the
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18. Anonymous. Papaverine Hydrochloride. In McEvoy GK (ed.). AHFS Drug
Information. American Society of Hospital Pharmacists, Bethesda, Maryland, 1990,
pp. 975-6.
19. Labrecque M, Dostaler LP, Rousselle R, Nyuyen T, Poirier S. Efficacy of nonsteroidal anti-inflammatory drugs in the treatment of acute renal colic: a metaanalysis. Arch Intern Med 1994; 154: 1381-7.
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colic. Eur J Clin Pharmacol 1991; 40: 543-6.
21. Marthak KV, Gokam AM, Rao AV, Sano SP, Mahanta RK, Seth RD, Chavda KD,
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diyprone/spasmolytic combination, and a single-center comparative study of
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1991; 12: 366-73.
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(abstract). Urol Res 1984; 12-45.
24. Sjodin JG. Effects of intravenous indomethacin during acute ureteral obstruction.
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renal pelvic smooth muscle in the rabbit. Br J Urol 1985; 57:390-3.
13
27. Kantor TG. The use of diclofenac in analgesia. The Am J Med 1986; 80(suppl 4B):
64-9.
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14
Table 1: Patients’ Characteristics
Drug
Diclofenac
Ketoprofen
Alverine
Hyoscine NBB
p
M
n=89
F
n=22
M
n=100
F
n=13
M
n=95
F
n=15
M
n=88
F
n=22
Sig
Age (yr):
Mean :
SD :
34.7
8.8
28.3
9.0
35.8
9.7
25.9
7.7
34.9
8.8
25.5
8.1
35.1
9.1
31.7
11.0
0.72a
NS
Weight (kg):
Mean :
SD :
67.7
14.5
63.1
12.6
72.1
17.7
55.2
12.6
69.8
13.1
64.7
20.7
66.9
13.4
72.4
15.5
0.39a
NS
Type of Pain:
a)
Acute:
b)
Subacute:
c)
Chronic:
50
21
18
13
8
1
54
35
11
5
6
1
59
21
14
10
5
0
57
20
10
15
4
3
0.16b
NS
Other Diseases:
a)
Present:
b)
Absent:
3
86
0
22
1
99
0
13
1
93
0
15
0
88
0
22
0.281b
NS
Urinalysis:
A) RBC:

Positive :

Negative :
40
49
9
13
32
68
3
10
43
52
5
10
27
61
7
15
0.93b
NS
B) Pus:

Positive:

Negative :
43
46
11
11
15
85
2
11
23
72
4
11
14
74
3
19
0.097b
NS
C) Crystals:

Positive:

Negative :
4
85
0
22
7
93
2
11
2
93
0
15
7
81
1
21
0.119b
NS
X-Ray:
a) Stone:
b) No stone:
16
73
2
20
11
89
2
11
15
80
0
15
13
75
5
17
0.691b
NS
Pain History:
a) Never before:
b) One week:
c) 2-3 weeks:
d) >4 weeks:
72
6
2
9
20
0
0
2
90
1
2
7
12
1
0
0
81
2
6
5
15
0
0
0
76
2
2
8
19
0
1
2
0.307b
NS
NS= Statistically significant, M=Males, F=Females
a. One-way analysis of variance (males and females combined)
b. Chi-square test (males and females combined)
15
Table 2. Pain Relief
Pain relief
NSAID
SPASMOLYTICS
Worse Pain
DS
n (%)
1 (0.9)
KET
n (%)
1 (0.9)
ALV
n (%)
18 (16.4)
HBB
n (%)
19 (17.3)
No Change
3 (2.7)
12 (10.6)
31 (28.2)
38 (34.5)
Moderate Relief
7 (6.3)
5 (4.4)
2 (1.8)
1 (0.9)
Complete Relief
100 (90.1)
95 (84.1)
59 (53.6)
52 (47.3)
111
113
110
110
Total
p< 0.0001 (S)
16
Table 3.
Pain relief before (b) and after (a) the second dose for patients who required a
second dose of the drug.
Treatment outcome
DS
(No. of Patients)
Worse Pain
No Change
Moderate Relief
Complete Relief
Total
KET
ALV
HBB
b
a
b
a
b
a
b
a
n
1
0
0
0
11
1
13
3
%
100
0
0
0
39.3
3.6
50
11.5
n
0
0
4
0
15
5
13
13
%
0
0
80
0
53.6
17.9
50
50
n
0
0
1
0
1
0
0
1
%
0
0
20
0
3.6
0
0
3.8
n.
0
1*
0
5
1
22
0
9
%
0
100
0
100
3.6
78.6
0
34.6
n
1
1
5
5
28
28
26
26
%
100
100
100
100
100
100
100
100
* Pain recurred after the first pain relief assessment.
p (before)=0.1113 (NS)
p (after) =0.0042 (S)
17
Table 4. Pain Intensity Difference (PID) (mean ± SEM)
Drug
Time
5 min
10 min
30 min
45 min
1 hr
2 hr
3 hr
DS
1.00 ± 0.18
1.63 ± 0.18
1.50 ± 0.40
1.53 ± 0.11
1.43 ± 0.11
1.31 ± 0.10
1.60 ± 0.05
KET
1.00 ± 1.00
0.83 ± 0.58
1.46 ± 0.18
1.36 ± 0.12
1.52 ± 0.17
1.25 ± 0.08
1.00 ± 0.18
ALV
-
1.00 ± 1.00
1.26 ± 0.67
0.73 ± 0.63
1.29 ± 0.22
1.00 ± 0.30
1.33 ± 0.19
HBB
-
0.77 ± 0.90
1.10 ± 0.35
1.33 ± 0.33
1.11 ± 0.16
1.00 ± 0.19
-
Table 4. Effect of route of administration of alverine and hyoscine N-butylbromide
on pain relief.
Treatment
Outcome
ALV
HBB
IV
IM
IV
IM
n (%)
n (%)
n (%)
n (%)
Worse Pain
6 (16.7)
12 (16.2)
8 (12.9)
11 (22.9)
No Change
11 (30.6)
20 (27)
22 (35.5)
16 (33.3)
Moderate Relief
1 (2.8)
1 (1.4)
0 (0)
1 (2.1)
Complete Relief
18 (50)
41 (55.4)
32 (51.6)
20 (41.7)
p (Sig)
Total
NS = Not Significant
0.9160 (NS)
36 (100)
74 (100)
0.3254 (NS)
62 (100)
48 (100)
Table 5. Effect of hyoscine N-butylbromide dose on pain relief.
Treatment Outcome
Dose
20 mg
40 mg
n (%)
n (%)
Worse Pain
7 (17.1)
12 (17.4)
No Change
12 (29.3)
26 (37.7)
Moderate Relief
0 (0)
1 (1.4)
Complete Relief
22 (53.7)
30 (43.5)
p = 0.6399 (NS)
20
Table 6. Blood pressure and Heart rate results.
Drug
Blood Pressure (mm Hg)
Heart Rate
Systolic
Diastolic
(Beat/min)
Diclofenac sodium
123.4 ± 16.4
79.3 ± 9.8
82.0 ± 10.5
Ketoprofen
132.0 ± 18.5
85.0 ± 10.4
80.2 ± 11.1
Alverine
128.5 ± 18.5
84.4 ± 10.7
84.7 ± 10.1
Hyoscine N-Butyl Br
129.4 ± 16.1
84.0 ± 9.6
83.7 ± 11.7
p (sig)
<0.001 (S)
0.0027 (S)
0.013 (S)
Total
128.4 ± 17.6
83.2 ± 10.4
82.6 ± 11.0
S=Statistically Significant.
21
Figure 1. Study Protocol
Patient with suspected RENAL or
URETERAL COLIC in ER
Diagnosis
Exclude
NO
Renal or
Ureteral Colic
confirmed?
YES
Lab Tests
& X-ray
Assign Medication
Randomly
Give First Dose
DISCHARGE
Pain after
15 min?
YES
Give Second Dose
NO
Monitor
Patient
Assess
Medication
NO
Pain after
15 min?
NO
YES
Pain after
15 min?
YES
Give Pentazocine
22
Give a Drug from
SECOND GROUP