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临床试验/CTRI/2024/11/077104
CTRI/2024/11/077104尚未招募2/3 期

Oral Preemptive analgesic efficacy in post operative pain , nausea and vomiting in third molar removal surgery - A Randomised control clinical trial

SUURYA KALAA MAKKALL NALANN MARUNDHAGHAM1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2024年12月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
129
试验地点
1
主要终点
Post operative pain , nausea and vomiting .

研究概览

简要总结

**Summary**

**Background**: Postoperative pain, nausea, and vomiting (PONV) are common complications following third molar (wisdom tooth) extraction, often necessitating effective pain management strategies. Oral preemptive analgesia, administered before surgery, is hypothesized to reduce these postoperative symptoms by mitigating the central sensitization associated with surgical trauma.

**Objective**: This randomized controlled clinical trial aimed to evaluate the efficacy of oral preemptive analgesia in reducing postoperative pain, nausea, and vomiting following third molar extraction.

**Methods**: A total of 129 participants, aged between 18 and 35 years, who required the surgical removal of impacted third molars, were recruited and randomly assigned into two groups. Group A (n=65) received a single dose of oral preemptive analgesic 30 minutes before surgery, while Group B (n=64) received a placebo. Postoperative pain levels were assessed using the Visual Analog Scale (VAS) at 6,12 and 24 hours post-surgery. The incidence and severity of nausea and vomiting were recorded using the Numeric Rating Scale (NRS) and monitored over a 24-hour period postoperatively.

**Results**: Group A reported significantly lower VAS pain scores compared to Group B at 6, 12, and 24 hours post-surgery (p<0.05). The incidence of nausea and vomiting was also markedly reduced in Group A, with fewer participants requiring rescue antiemetics compared to Group B (p<0.05). Additionally, participants in Group A demonstrated a quicker return to normal activities.

**Conclusion**: Preemptive oral analgesia significantly reduced postoperative pain and the incidence of nausea and vomiting following third molar surgery. This strategy could improve patient comfort and recovery, suggesting its utility as part of routine perioperative management in oral surgery.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients requiring surgical removal of impacted teeth in mandible following by inferior alveolar nerve block.

排除标准

  • Patient already on analgesics medication, children, patients with peri apical pathology and special care patients.

结局指标

主要结局

Post operative pain , nausea and vomiting .

时间窗: Post operative pain , nausea and vomiting .

次要结局

  • Patient’s comfort and general condition post operatively(Patient’s comfort and general condition post operatively)

研究者

发起方
SUURYA KALAA MAKKALL NALANN MARUNDHAGHAM
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Sunil Yesvanthu S V

Saveetha Dental College and Hospital ,SIMATS

研究点 (1)

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