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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Renal Colic

Treatments: Drug: Balanced analgesia using ketorolac and morphine; Drug: Pain control with single analgesics (ketorolac); Drug: Ketorolac and nefopam balanced analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01543165

B-1112/141-011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 111 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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111 participants in 3 patient groups, including a placebo group

Group 1

Experimental group

Description:

Sequential intravenous administration of ketorolac and nefopam

Treatment:

Drug: Ketorolac and nefopam balanced analgesia

Group 2

Active Comparator group

Description:

Sequential intravenous administration of ketorolac and morphine

Treatment:

Drug: Balanced analgesia using ketorolac and morphine

Group 3

Placebo Comparator group

Description:

Intravenous administration of ketorolac

Treatment:

Drug: Pain control with single analgesics (ketorolac)