Clinical trial NCT02711891: Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing
Official title: Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing: A Randomized Double Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: fingerstick
opioid
heelstick
loperamide
topical opioid
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates topical loperamide 5% gel in reducing pain during repeat finger lancing (finger stick) in healthy adults. Half of participants received 5% loperamide gel applied to their fingertip prior to their second lance and the other half received the gel only.

Detailed description: Lancing the finger and heel to obtain capillary blood for specimen collection and diagnostic testing is a painful and tissue damaging procedure. With each lance, there is direct splicing of capillaries along with free nerve endings resulting in an immediate localized pain response and hyperalgesia from the release of pain producing substances. Opioid agonists (morphine, fentanyl, loperamide) have demonstrated significant analgesia when locally injected or topically applied to a site of inflammation/injury in animal models.

Loperamide, a piperdine derivative with a structure similar to the synthetic opioid meperidine, has strong affinity for Mu opioid receptors. It was approved by the FDA in 1969 as an anti-diarrheal agent with Mu opioid activity mimicked the constipating effects of other opioids, but with markedly reduced CNS effects due to its affinity for p-glycoprotein, preventing crossing the blood brain barrier (BBB) under normal circumstances.

This prospective, double-blind, repeated measures, randomized investigational new drug trial used loperamide developed as a topical gel in 34 adult participants to determine its analgesic effects during repeat finger lancing. The investigators also assessed for any local skin reaction to the gel application and for any constipation or abdominal cramping which might be evidence of systemic absorption and Mu opioid agonist activity on the gut.

This study would be applicable for use in 28.9 million adults who are diabetic and require finger lancing for blood glucose monitoring and the high risk newborn population who require repeat heel lancing for specimen collection.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers willing to have 2 consecutive finger sticks completed.

Exclusion Criteria:

* Participants are excluded if they have a history of drug induced hypersensitivity reactions; took any anti-inflammatory medications in the past 12 hours; if they routinely performed finger lancing for blood specimen monitoring (e.g. diabetes); or had calloused fingers pads.

Primary outcomes:
measure: Pain - Numeric Rating Scale
timeFrame: Within one minute following each lance
measure: Pain - Comparative Pain Scale
timeFrame: Within one minute of the second lance, participants will be asked to circle their comparison pain rating to the first lance delivered 40 minutes earlier to the same digit.
Secondary outcomes:
measure: 24 Hour Numeric Pain (0 to 10 Scale) in the Lanced Finger Site.
timeFrame: 24 hours following the second lance.
measure: 24 Hour Sensitivity in Lanced Finger to Touch and Pressure
timeFrame: 24 hours post lancing.
measure: Change in Beats Per Minute (BPM) Within Groups During Lance One and Lance Two Procedure
timeFrame: Average of BPM during each phase of the lance procedure (lance, specimen collection, recovery)
measure: Safety- Number of Participants With Treatment Related Adverse Events as Assessed by the CTCAE V.4
timeFrame: Direct observation of treatment site at one minute and 30 minutes. Participant report at 24 hours if any redness is present on the forearm.
measure: Safety - Number of Participants With Treatment Related Adverse Gastrointestinal Disorders Using the CTCAE V. 4 With Focus on Abdominal Pain, Constipation and Diarrhea
timeFrame: 24 hour participant report
Other outcomes:
Locations:
Study officials:
References:
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