Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic

Study Overview
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Brief Summary
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This study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain.

Detailed Description
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The balanced analgesia regimen using both ketorolac and morphine is the most effective choice in controlling urolithiasis related acute pain. Previous animal and human studies reported that combination regimen of ketoprofen and nefopam showed synergistic effect in pain control. We hypothesized that using nefopam instead of morphine for ketorolac based combination analgesia will produce similar pain reduction without causing opioid-related side effect.

Official Title
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A Single Center, Prospective Randomized Double-blind Trial: Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic

Conditions
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Renal Colic

Intervention / Treatment
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* Drug: Ketorolac and nefopam balanced analgesia
* Drug: Balanced analgesia using ketorolac and morphine
* Drug: Pain control with single analgesics (ketorolac)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute flank with visual analog pain scale score equal or more than 5 and most possible diagnosis after initial clinical exam is acute renal colic Exclusion Criteria: Pregnant or lactating women Patients whose use of any of the study drugs is contraindicated Patients with documented renal or hepatic failure or those with clinical findings suggesting the diagnoses Recent episode of acute myocardial infarction or patients with significant heart failure Patients with documented gastric/duodenal ulcer or those with clinical findings suggesting the diagnoses Patients with bleeding tendency Patients who have history of any seizure Patients with documented organic brain injury Patients taking warfarin Patients whose primary diagnosis is not renal colic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Sequential intravenous administration of ketorolac and nefopam | Drug: Ketorolac and nefopam balanced analgesia<br>* Sequential intravenous administration of ketorolac and nefopam<br>|
| Active Comparator: Group 2<br>Sequential intravenous administration of ketorolac and morphine | Drug: Balanced analgesia using ketorolac and morphine<br>* Sequential intravenous administration of ketorolac and morphine<br>|
| Placebo Comparator: Group 3<br>Intravenous administration of ketorolac | Drug: Pain control with single analgesics (ketorolac)<br>* This arm do not use balanced analgesia. Instead, ketorolac IV administration followed by 50cc normal saline administration (for blinding) will be used in this group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of pain reduction by visual analog pain scale |  | At 30 and 60 minutes after primary study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional analgesia requested by enrolled patients |  | At 30 and 60 minutes after primary study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal colic, Analgesia, Ketorolac, Nefopam