Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing
Condition: Pain
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Loperamide; Drug, placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): Following lance one, 0.2 grams of loperamide 5% gel was applied from a sterile syringe to the participants previous lance site within an 8 mm diameter circular plastic mold. The loperamide gel was rubbed lightly on the skin surface for one minute using a gloved finger swirled into the mold site. The mold was removed and the site was covered with a transparent occlusive dressing for 30 minutes. At 30 minutes the gel was removed with gauze, the skin cleaned with an alcohol wipe and the second lance was done within the same location as the first. The loperamide gel was also swabbed to the forearm within the 8 mm mold and left in place for 30 minutes.; Following lance one, 0.2 grams of gel alone was applied to the participants previous lance site within an 8mm diameter circular plastic mold. The gel was rubbed lightly on the skin surface for one minute using a gloved finger swirled into the mold site. The mold was removed and the site was covered with a transparent occlusive dressing left in place for 30 minutes. At 30 minutes the gel was removed with gauze, the skin cleaned with an alcohol wipe and the second lance was done within the same location as the first. The placebo gel was also swabbed to the forearm within the 8 mm mold and left in place for 30 minutes.
Other intervention name(s): Mu opioid receptor agonist
Intervention MeSH terms: Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: fingerstick; opioid; heelstick; loperamide; topical opioid