Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing: A Randomized Double Blind Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Pain - Numeric Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers willing to have 2 consecutive finger sticks completed.
排除标准
- •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.
研究组 & 干预措施
5% Loperamide gel
Participants received 5% loperamide gel (0.2gm equivalent to 10 mg) applied following a single surgilance to the 5th digit. The loperamide gel was applied 10 minutes following the first lance, rubbed in for one minute within an 8 mm mold surrounding the lance site. The mold was removed and the gel was covered with a transparent occlusive dressing and left in place for 30 minutes. The forearm was also swabbed with the loperamide gel which was left in place for 30 minutes. The placebo gel contained the same ingredients without the loperamide. The loperamide gel formulation includes: Loperamide 5%, Propylene Glycol; Ethanol (190 proof USP); Ethyl acetate; and Klucel HF 1%.
干预措施: Loperamide (Drug)
Placebo gel
Participants received placebo gel (0.2gm) applied following a single surgilance to the 5th digit. The placebo gel was applied 10 minutes following the first lance, rubbed in for one minute within an 8 mm mold surrounding the lance site. The mold was removed and the gel was covered with a transparent occlusive dressing and left in place for 30 minutes. The forearm was also swabbed with the placebo gel which was left in place for 30 minutes. .The placebo gel contained the same ingredients without the loperamide. The placebo gel formulation includes: Propylene Glycol; Ethanol (190 proof USP); Ethyl acetate; and Klucel HF 1%.
干预措施: Drug, placebo gel (Drug)
结局指标
主要结局
Pain - Numeric Rating Scale
时间窗: Within one minute following each lance
Subject responded to "Please mark the degree of pain you felt following the lance" and drew a line on a 0 (no pain) to 10 (worst possible pain) scale within one minute of the lance.
Pain - Comparative Pain Scale
时间窗: 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.
Within one minute following the second lance, subjects were asked "In comparison to the first finger stick, how would you rate the pain of the second": much less, a little less, about the same, a little more or much more.
次要结局
- 24 Hour Numeric Pain (0 to 10 Scale) in the Lanced Finger Site.(24 hours following the second lance.)
- 24 Hour Sensitivity in Lanced Finger to Touch and Pressure(24 hours post lancing.)
- Change in Beats Per Minute (BPM) Within Groups During Lance One and Lance Two Procedure(Average of BPM during each phase of the lance procedure (lance, specimen collection, recovery))
- Safety- Number of Participants With Treatment Related Adverse Events as Assessed by the CTCAE V.4(Direct observation of treatment site at one minute and 30 minutes. Participant report at 24 hours if any redness is present on the forearm.)
- Safety - Number of Participants With Treatment Related Adverse Gastrointestinal Disorders Using the CTCAE V. 4 With Focus on Abdominal Pain, Constipation and Diarrhea(24 hour participant report)
研究者
Kathleen Heneghan
Primary Investigator
Rush University Medical Center