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临床试验/NCT02862691
NCT02862691终止2 期

A Comparison of the Analgesic Efficacy of Oral Opioid Medication vs. Injected Local Anesthetic in Emergency Department Patients With Toothache

Stony Brook University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
2
试验地点
1
主要终点
Percentage of patients with significant pain relief at the end of the study period

研究概览

简要总结

The goal of this study is to compare the speed and adequacy of pain relief in Emergency Department patients with a toothache after an oral analgesic or a local anesthetic administered as a nerve block or by local infiltration.

详细描述

All adult patients reporting to the Stony Brook Medical Center Emergency Department with a toothache will be assessed for inclusion criteria. Patients who agree to participate in the study and meet the study criteria will be asked to rate their pain using an 11-item verbal numeric pain scale from 0 to 10, from none to worst. The patient will then be randomized to either two Percocet oral tablets (acetaminophen 325 mg and oxycodone 5 mg), or a single dose of Bupivicaine (as a root block for maxillary teeth or as a local infiltration for mandibular teeth). The intervention given to any particular patient will be determined using a randomization protocol described in Treatment Allocation. The patients will be stratified into depending on whether they have mandibular or maxillary tooth pain in order to account for any difference in outcome based on method of Bupivicaine administration (local block for maxillary teeth and nerve block for mandibular teeth). Half of the included patients will have maxillary toothaches and half will have mandibular toothaches. Administration of additional prescriptions and recommendations will be given as deemed necessary by the dental resident and attending physician (such as antibiotics or additional analgesics).

Measures and Outcomes Following the administration of treatment, the patient will be asked to rate their pain on the verbal numeric pain scale every 5 minutes up to 30 minutes following treatment. The pain of injection will also be measured, immediately following injection on the same pain scale. If after the first 30 minutes the patient still requires additional analgesia, then other analgesic interventions may be given at the discretion of the dental resident and attending physician.

The primary outcome will be the percentage of patients with significant pain relief at the end of the study period of 30 minutes. Patients whose pain is reduced from severe (7-10) to mild (0-3) will be considered as having a meaningful reduction in pain. Secondary outcomes will be the absolute change in pain severity at 30 minutes calculated by subtracting the 30-minute pain score from the initial pre-treatment pain score as well as the time to a 50% reduction in pain severity.

At the end of the trial patient satisfaction with the method of analgesia will be measured on a 5 point Likert scale: extremely dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, and extremely satisfied. Patients will also be asked if they would choose the same treatment for future toothaches.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who present to the ED with a chief complaint of toothache, and a pain intensity rating of at least a 7 on an 11 item verbal numeric scale (from 0 or no pain to 10 or worst imaginable pain) will be eligible for enrollment.
  • Patient should have the capacity to provide informed consent.

排除标准

  • Patients presenting with a toothache due to trauma or post-operative procedure will be excluded as well as those requiring drainage of a dental abscess.
  • Patients who have any contraindications to the medications used in the study (allergy, history of GI bleeding, etc.).
  • Patients who cannot remain in the ED for at least 1 hour after study drug administration or do not have a ride home (if receiving Percocet) will be excluded from the study.

研究组 & 干预措施

Oral analgesic

Active Comparator

2 tablets of acetaminophen 325 mg/ oxycodone 5 mg orally once

干预措施: Acetaminophen/Oxycodone (Oral analgesic) (Drug)

Injectable local anesthetic

Experimental

local injection or nerve block with bupivicaine 0.5%

干预措施: Bupivicaine (Injectable local anesthetic) (Drug)

结局指标

主要结局

Percentage of patients with significant pain relief at the end of the study period

时间窗: 60 minutes

Patients whose pain is reduced from severe (7-10) to mild (0-3) will be considered as having a meaningful reduction in pain.

次要结局

  • The time to a 50% reduction in pain severity(60 minutes)
  • Absolute change in pain severity(60 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Singer

Vice Chairman of Reserach

Stony Brook University

研究点 (1)

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