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临床试验/NCT01944085
NCT01944085已完成不适用

Percutaneous Pin Removal in the Outpatient Clinic - do Children Require Analgesia? A Randomized Controlled Trial

KK Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
1
主要终点
Pain Score (0 -10)

研究概览

简要总结

This is a simple randomised clinical trial to study if non-narcotic analgesia reduces the pain score and pulse rate of children who undergo removal of percutaneous pins in the outpatient clinic.

Inclusion criteria:

  • 5-12 years of age
  • 2 or 3 percutaneous pins in either elbow

Exclusion criteria:

  • documented or suspected allergies to acetaminophen, ibuprofen

Patients enrolled in the study are instructed not take additional analgesia prior to the clinic visit (risk of overdosage explained). This is verified by clinic nurses conducting the trial.

At the clinic visit, they are randomized into one of three groups

  1. acetaminophen; 2. ibuprofen; or 3. Vitamin C (Placebo).

They are served the 'medication' (weight-appropriate dose) and the pins are removed in the clinic an hour later.

Pain score (Wong-Baker scale) and pulse rate are measured before pin removal, immediately following pin removal, and 10 minutes after pin removal.

The study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do not decrease pain score and pulse rate associated with the pin removal procedure.

详细描述

See Brief Summary

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age: 5-12 inclusive
  • 2 or 3 percutaneous pins in either elbow

排除标准

  • documented or suspected allergies to acetaminophen or ibuprofen

研究组 & 干预措施

Acetaminophen

Active Comparator

Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose)

干预措施: Acetaminophen (Drug)

Ibuprofen

Active Comparator

Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose)

干预措施: Ibuprofen (Drug)

Vitamin C (Placebo)

Placebo Comparator

Vitamin C was administered 1 hour prior to pin removal (weight dependent dose)

干预措施: Vitamin C (Other)

结局指标

主要结局

Pain Score (0 -10)

时间窗: 10 minutes after pin removal

Pain score is measured using the Wong-Baker Scale

次要结局

  • Pulse rate(10 minutes after pin removal)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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