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Treatment of acute renal colic rectal diclofenac sodium

A Randomized Clinical Trail. J Clin Trials 5: This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Renal colic is a type of abdominal pain commonly caused by obstructive stones.

The aim of this study was to compare the safety and efficacy of rectal diclofenac sodium RDS and intramuscular pethidine IMP injection in acute renal colic.

Pain relief was measured by asking the participants at 10, 20 and 30 minutes after taking each drug. Although there was no significant difference in analgesic effect between the two drugs, using diclofenac sodium in suppository form is highly recommended for renal colic patients because of availability, being less expensive, safety, and its self-administration.

Keywords Renal colic; Diclofenac sodium; Pethidine ; Analgesia Introduction Renal colic is a common urological emergency often caused by the movement of ureteral stones and characterized by severe pain.

Managing patients with renal colic in primary care: Know when to hold them

Patients describe this pain as the most severe and excruciating situation ever experienced [ 1 ]. The renal colic pain is usually related to the contraction of ureter soft muscles due to the presence of stone [ 3 ].

Therefore, the most important consideration in the emergency management of renal colic is pain control and relief [ 2 ]. Among opioids, morphine and pethidine were used traditionally, but they have been replaced by NSAIDs because of their side effects such as addiction, constipationrespiratory depression and mental changes [ 56 ].

Experimental studies have suggested that prostaglandins play an important role in producing pain in renal colic and therefore, anti-prostaglandins can eliminate or diminish this type of pain [ 78 ].

Diclofenac 2,6-dichlorophenylamino phenylacetic acid is an NSAIDs which is used for reducing inflammation and is an analgesia in certain conditions such as renal colic [ 9 ].

Its exact mechanism of action is not entirely known. However, the primary mechanism responsible for its analgesic effect is the decline in prostaglandin synthesis by inhibition of cyclooxygenase, a basic enzyme in the prostaglandin synthesis pathway [ 10 ].

Still, pethidine is also a popular synthetic analgesic opioid of the phenylpiperidine class [ 11 ]. No study has reported serious adverse consequences for pethidine. This may be because of the short follow-up period and failure to specifically record renal dysfunction and gastrointestinal bleeding. Therefore, these results should be reexamined carefully [ 3 ]. When a single bolus of analgesia is used, NSAIDs are recommended as the first line of treatment by European urological association [ 12 ].

However, in some conditions such as having severe pain, using opioids is inevitable.

Renal or ureteric colic - acute

The aim of this study was to compare the analgesic effect of rectal diclofenac sodium RDS and intramuscular pethidine IMP in patients with renal colic. The study protocol was approved by the ethics committee of Jahrom University of Medical Sciences. All patients who enrolled in this study signed an informed consent form. However, 45 patients who had a history of allergy to NSAIDshemorrhoids and anal fissures, peptic ulcerscoagulopathy, inflammatory bowel disease, pregnancy, ischemic coronary diseases, chronic obstructive pulmonary disease, and liver or renal failure were excluded from the study.

So, 541 patients were selected as participants and were randomly allocated into two groups with the approximately ratio of 1: The first group 266 participants received a single 100 mg dosage of RDS and the other group 275 participants received a single 50 mg dosage of IMP.

Randomization was performed using a computer-generated random permuted block method. All participants were followed up and included in the analysis without any exclusion. The participants reported their pain and its declining status at 10, 20 and 30 minutes after receiving the drug. The participants were blind to their previous reports. Their pain and response to medication were evaluated using visual analog scale system VAS [ 12 ]. The outcome was the change in pain intensity at 10, 20, 30 and more than 30 minutes follow up.

Statistical Analysis All data were presented as numbers and percentages. Chi-square test was used for analysis of association between type of treatment and response to each treatment using statistical package for social sciences SPSS software version 16.

In this article

P value less than 0. There were 351 men 64. Percentages of participants who responded to each drug are shown in Table 1. According to these data, the percentage of patients that experienced pain reduction at 10 and 20 minutes after using of the drug in RDS group was higher than IMP group 45.

Figure 2 illustrates the flowchart of the study. Discussion Nowadays, urolithiasis a common health problem worldwide and renal colic may be the first presenting symptom. Relief of the acute pain is the mainstay and first step in the management of renal colic. Alpha blockers also reduce the recurrence of the pain episodes. Still, this drug may alter the renal glomerular filtration rate in patients with renal insufficiency.

  • So, 541 patients were selected as participants and were randomly allocated into two groups with the approximately ratio of 1;
  • This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited;
  • Arrange urgent referral to urology within 7 days of the onset of symptoms if possible so that diagnostic investigations can be done to confirm the diagnosis and to assess the likelihood of spontaneous stone passage — see Follow up and referral for more information;
  • If the serum calcium level is high greater than 2;
  • Its exact mechanism of action is not entirely known;
  • Still, this drug may alter the renal glomerular filtration rate in patients with renal insufficiency.

However, there is no evidence of its adverse effect on the kidney with normal function [ 12 ]. Traditionally, opioids and NSAIDs were used for treatment of acute renal colic with almost equal efficacy [ 1314 ]. However, the latter has few side effects [ 78 ]. Oral consumption of analgesics usually is not suggested due to nausea and low effect in this route.

Therefore, intravenous or intramuscular methods are more acceptable. Intramuscular method seems better because it can be administered faster and there is no need to monitor the patient in emergency unit [ 15 ]. If it is not contraindicated and tolerated by the patient, suppository route rectal seems better, because it will be self-administrative, with no need of injection by an experienced medical staff.

In previous studies, the efficacy of diclofenac sodium versus pethidine in acute renal colic was evaluated. In a study by Hetherington and Philip on 58 renal colic patients, it had been concluded that 75 mg of diclofenac sodium in intramuscular route was more effective than 100 mg of pethdine in the management of acute renal colic and had fewer side effects [ 7 ].

Also, Thompson and colleagues reported that RDS provided potent, specific analgesia in renal colic. They concluded that diclofenac is superior to pethidine because its effect starts at a similar time but lasts longer [ 8 ]. In a review by Duqenne and colleagues the indications of spasmolytics in renal colic were studied.

This study revealed that although they are used commonly in emergency department, their use is not recommended due to less efficacy and side effects and it is better to use diclofenac instead [ 16 ]. In a randomized trial on the efficacy of intramuscular diclofenac and tramadol, Salameh and colleagues concluded that diclofenac has better response as a single medication and suggested tramadol in cases that diclofenac could not be use [ 14 ].

Rojas and colleagues have reviewed the current practice in the emergency departments and concluded that more than half of physicians prescribed NSAIDs for treatment of renal colic in combination with opioids [ 17 ].

In another study the clinical efficacy of the suppository Spasmofen a combination of 100 mg of Icetoprofen and 10 mg of Hyoscine was compared with intravenous ketorolac. The results revealed the safety and effectiveness of rectal spasmofen in the pain relief of renal colic [ 18 ]. They suggested that NSAIDs are highly effective in the treatment of renal colic, but may have hazards in patients with gastrointestinal ulcers, cardiac function impairment and renal insufficiency.

They also found that NSAIDs may diminish the chance of colic episode recurrence and hospital referral, but do not alter the passing of the stone [ 19 ]. The fact that diclofenac can be self-administered and is not an opiate, makes it a useful drug in general practice, especially for patients with recurrent renal colic. Pethidine as a synthetic opioid is about one tenth as potent as morphine. Pethidine has more lipid solubility than morphine, elimination half-life of two to four hours and duration of action of only two to three hours [ 20 ].

In a double blind clinical trial, analgesic efficacy, patient satisfaction and side effects of morphine and pethidine in patients with clinically suspected renal colic were evaluated. Although, the results demonstrated that there were no significant differences between morphine and pethidine in respect to any of the measured parameters, the authors concluded that due to the well-known adverse effects related to pethidine, morphine should be the preferred agent in suspected renal colic, when an analgesic opioid is to be used [ 21 ].

Moreover, it had been reported that norpethidine, the predominant metabolite of pethidine, is potentially toxic and causes central nervous system excitability such as tremors, myoclonus or seizures. Also, accumulation of norpethidine has been seen in treatment of acute renal colic rectal diclofenac sodium with normal kidneys, particularly with large doses or frequent dosing intervals [ 22 ] Figure 3.

Limitations of the Study We had some limitations in this study. Moreover, this form of NSAIDs is contraindicated in those with anorectal disorders such as hemorrhoid and anal fissure. Also, whenever a patient responded to medication e. Conclusion This clinical trial demonstrated that although, the percentage of patients with diminished pain in 10 and 20 min after using of RDS was higher than IMP, this difference was not significant.

Therefore, the efficacy of these two drugs is similar. However, because of availability, being less expensive, safety, and its self-administration, use of RDS is highly recommended in renal colic compared to IMP.

Because of treatment of acute renal colic rectal diclofenac sodium adverse effects of pethidine and its metabolite, i. Moreover, clinical and paraclinical studies about possible side effects of rectal diclofenac sodium are highly suggested.

Although, our study suggested suppository form of NSAIDs as the fist line for the treatment of renal colic with an acceptable short time efficacy, their long term effects should also be further evaluated in future studies. Also, the authors would like to thank Seyed Muhammed Hussein Mousavinasab for his sincere cooperation in editing this text.