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临床试验/NCT03049878
NCT03049878已完成4 期

Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery: a Randomized, Split-mouth, Placebo-controller, Double-blind Clinical Trial

University of Roma La Sapienza0 个研究点目标入组 32 人开始时间: 2013年2月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
32
主要终点
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.

研究概览

简要总结

Objectives:

The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar.

Materials and Methods:

The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • absence of systemic pathologies (ASA class I);
  • non-smoker;
  • not pregnant or lactating;
  • good oral hygiene;
  • no drug consumption for 10 days before the operation;
  • bilateral impacted mandibular third molars with comparable position, depth and inclination;
  • presence of the first and second molars;
  • absence of painful symptoms and associated inflammatory or osteolytic pathologies in a radiographic examination;
  • extraction difficulty index of >7 according to Pederson's scale and a degree of IV (complex procedures) on a modified version of Parant's scale.

排除标准

  • 未提供

研究组 & 干预措施

analgesic group

Active Comparator

preoperative oral dose of paracetamol-codeine

干预措施: Paracetamol Codeine (Drug)

placebo group

Placebo Comparator

preoperative placebo (starch)

干预措施: Placebo Oral Tablet (Drug)

结局指标

主要结局

Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.

时间窗: All study participants were asked to record the pain intensity score at 11:00 pm during the operative day

The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")

Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.

时间窗: All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery

The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")

Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.

时间窗: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery

The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Paola Cristalli

DDS PhD, Clinical Professor

University of Roma La Sapienza

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