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NCT Number: NCT04160520

Pramipexole and Morphine for Renal Colic

Opioid analgesics are among the most commonly prescribed class of medications in the US. While opioids may effectively control pain and other sensory disorders under acute conditions, the rates of misuse/abuse and accidental overdose have reached epidemic proportions. Clinicians are being challenged to find alternatives to opioid analgesics, or to reduce their use in treating pain whenever possible. Pre-clinical studies have shown that combining morphine (opioid drug) with pramipexole (dopamine 3 receptor agonist with some D2/D4 action) provides superior analgesia against painful stimuli than morphine alone. This analgesia is maintained even when the dose of morphine is lowered to a dose that is not effective on its own. A recent case report describes the use of this combination to restore pain control in a patient with restless legs syndrome, for which opioids alone have lost their effectiveness (Happe S, Clemens S and Brewer KL, In Review). This application proposes to establish a new therapeutic approach for treatment of a pain associated with renal colic (a common painful condition) using a novel combination of 2 existing, FDA-approved drugs. The immediate goal is to demonstrate that this drug combination can provide similar analgesia to opioid alone, and that analgesia is maintained when the opioid dose is reduced by 50%.

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Key information

Conditions

Renal Colic Agnosia Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

19 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vidant Medical Center ED

Greenville, North Carolina, 27834, United States

About this study

This is a double-blinded randomized controlled trial to take place in the Vidant Medical Center (VMC) Emergency Department (ED). A convenience sample of 96 participants will be drawn from patients presenting to the ED presentation with pain associated with suspected renal colic who do not experience pain relief after initial treatment with nonsteroidal anti-inflammatories.

Written informed consent will be sought by a study team member after screening to ensure all inclusion criteria and no exclusion criteria are met. Once a patient has consented, they will be randomized into 1 of 2 study arms: Arm 1 (Control arm) = 0.1mg/kg of intravenous morphine + placebo pill, single dose Arm 2 (Study arm) = 0.05mg/kg intravenous morphine + 0.25mg pramipexole, single dose. Both arms include a maximum dose of 10mg/kg for the IV morphine. Pain scores will be obtained prior to administration of study drugs, and at 15-minute intervals (+/- 2 mins) after treatment for up to 2 hours, or discharge from the ED. Subjective response to each drug treatment will also be assessed every 15 minutes (+/- 2 mins) after treatment for up to 2 hours, or discharge from ED. Morphine will have a max dose of 10mg IV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 19 - 65
  • ED presentation with pain associated with suspected renal colic
  • Patient reported failure to achieve pain relief with NSAID treatment in ED (additional pain treatment needed per treatment team)

Exclusion criteria

  • Age < 19 or ≥ 66
  • Allergy to any study medication
  • Known pregnancy or breastfeeding
  • Received opioid prior to enrollment
  • Received IV Lidocaine during current ED visit
  • Known chronic renal disease
  • Currently taking any dopamine receptor agonist or antagonists (Do I need to list?)
  • Unable to consent

Treatment and study plan

Pramipexole

Drug

Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.

Morphine

Drug

Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.

Placebo oral tablet

Drug

Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.

Primary outcomes

  1. Proportion of patients who have an effective analgesic response (defined as at least a 50% improvement in pain scores) at 120 minutes post-randomization.

    Time frame: 120 minutes

    Pain scores used are the numerical rating scale (0 low to 10 high) or visual analogue scale (0 low to 100mm high).

  2. Total dose of opioid received at 120 minutes in patients reporting a reduction in pain scores from baseline.

    Time frame: 120 minutes

    Dose of opioid measured in mg/kg

  3. Proportion of patients who require rescue medications at 30 minutes post-randomization.

    Time frame: 30 minutes

Secondary outcomes

  1. Time to reach effective pain reduction (defined as at least a 50% improvement in pain scores) within 120 minutes of treatment.

    Time frame: 120 minutes

    Pain scores used are the numerical rating scale (0 low to 10 high) or visual analogue scale (0 low to 100mm high).

  2. Subjective effects of the drugs measured by scores on the drug effects questionnaire.

    Time frame: 120 minutes

    Drug effects questionnaire rates symptoms from 'not at all' at 0mm to 'extremely' at 100mm.

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Official study title

Adjuvant Treatment With Pramipexole to Reduce the Dose of Opioids Necessary for Analgesia in Acute Renal Colic

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 13, 2019
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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