The Effect of Dexamethasone on Short Term Patient Response: Intravenous vs. Oral Administration
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 21-point numerical pain rating scale (NRS-21)
研究概览
简要总结
Possible participants will be scheduled to have 2 gum flap surgeries done on 2 similar surgical sites in the mouth. The study looks at two different ways of giving dexamethasone, a medication used to reduce inflammation. The researchers want to learn if taking dexamethasone by mouth works similarly to receiving dexamethasone through the participant's vein (intravenous, or IV) in reducing short-term pain, swelling, and pain medication after periodontal (gum) flap surgery.
The periodontal evaluation, treatment planning, IV sedation, gum surgery, sutures, and usual postoperative care are part of standard care and would be done even if a participant does not join the study. After joining the study, participants will be randomly assigned to the order in which they receive dexamethasone. At one surgery, participants will receive IV dexamethasone plus oral placebo (an inactive substance that looks the same but does not contain dexamethasone). At the next surgery, participants will receive oral dexamethasone plus IV placebo. As part of the study, participants will be asked to record your pain, swelling and any other medication use.
详细描述
There will be two randomized treatment sequences and two study intervention conditions: intravenous dexamethasone with oral placebo, and oral dexamethasone with intravenous placebo. Each participant will receive both intervention conditions and will serve as his or her own control. This cross-over design was selected to reduce between-participant variability in pain perception, inflammatory response, medication use, and healing patterns. The matched placebo blinding approach was selected to preserve blinding while allowing comparison of two different routes of administration.
The study intervention consists of a single preoperative dose of dexamethasone administered either intravenously or orally prior to each periodontal flap surgery. Placebo will be administered by the alternate route at each surgical visit to maintain blinding. The intervention duration for each surgical visit is limited to the single preoperative dosing event. Follow-up outcome assessments will occur at 12, 24, 48 and 72 hours after each periodontal surgery.
No separate placebo-only or no-treatment control group will be used because the primary study question is whether oral dexamethasone provides comparable short-term patient-centered outcomes to intravenous dexamethasone. Prior periodontal studies have already evaluated dexamethasone compared with placebo or control therapy. In this design, each participant serves as his or her own control by receiving dexamethasone through both routes during two similar surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomization schedule will be computer-generated by a study statistician or designated study team member who is not involved in surgical treatment or outcome assessment. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes or an equivalent secure allocation system. The allocation will be implemented by an unblinded study team member or pharmacy-designated personnel responsible for preparing the active and placebo interventions. Participants, treating surgeons, supervising faculty, and outcome assessors will remain blinded to the active route of dexamethasone administration whenever feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Diagnosis of periodontitis and treatment plan recommending two similar periodontal flap surgical procedures.
- •The two planned periodontal surgical sites must be considered clinically similar based on extent and severity of periodontal disease, and suitable for a cross-over study design.
- •Able and willing to undergo the planned periodontal flap surgeries with IV conscious sedation.
- •Able to understand the study procedures and willing to sign a written informed consent document.
- •Fluent in reading English, because the postoperative questionnaires and patient-reported outcome instruments will be administered in English.
- •Able and willing to use the study paper survey to complete postoperative pain, swelling, and analgesic-use assessments.
- •Willing and able to comply with all study procedures, including postoperative outcome reporting at 12, 24, 48 and 72 hours after each surgery.
- •Resides within 50 miles of the University of Texas San Antonio School of Dentistry to facilitate completion of study visits, postoperative follow-up, and timely evaluation of any postoperative concerns.
排除标准
- •Unable to undergo periodontal surgery because of uncontrolled systemic disease, poor oral hygiene, or any clinical condition that, in the judgment of the treating clinician or Principal Investigator, would make periodontal surgery or study participation unsafe.
- •Pregnancy. Pregnant participants will be excluded because of potential medication-, surgical-, and sedation-related considerations. Pregnancy status will initially be assessed by participant self-report during pre-screening prior to informed consent and will be reconfirmed by participant self-report after informed consent and before randomization. Participants of childbearing potential will also be asked to confirm a negative pregnancy status with a urine pregnancy test before each surgical visit and before administration of study medication/placebo or IV sedation. Participants will be instructed to notify the study team if they become pregnant or believe they may be pregnant at any time during the study.
- •Diabetes mellitus.
- •Allergy to dexamethasone or IV fluid/saline, or any component of the oral or IV placebo formulation.
- •Chronic use (≥4 weeks) of anti-inflammatory, analgesic, or corticosteroid medications within the past 6 months.
- •Not fluent in reading English.
- •Inability to use the study paper survey to complete postoperative pain, swelling, and analgesic-use assessments.
- •Unwillingness to receive IV sedation or IV access.
- •Residence more than 50 miles from the UT Health San Antonio School of Dentistry.
研究组 & 干预措施
Sequence A Cohort
Surgery 1: IV Dexamethasone plus oral placebo Surgery 2: Oral Dexamethasone plus IV placebo
干预措施: Placebo capsule (Other)
Sequence B Cohort
Surgery 1: Oral Dexamethasone plus IV placebo Surgery 2: IV Dexamethasone plus oral placebo
干预措施: Dexamethasone Capsule (Drug)
Sequence B Cohort
Surgery 1: Oral Dexamethasone plus IV placebo Surgery 2: IV Dexamethasone plus oral placebo
干预措施: Placebo IV administration (Other)
Sequence A Cohort
Surgery 1: IV Dexamethasone plus oral placebo Surgery 2: Oral Dexamethasone plus IV placebo
干预措施: Dexamethasone IV injection (Drug)
结局指标
主要结局
21-point numerical pain rating scale (NRS-21)
时间窗: 12 to 72 hours post surgery
Change in pain on NRS-21, a 21 item scale that is scored using a numeric scale where patients choose from 0-20: 0: No pain at all 1 - 6: Mild pain (noticeable but doesn't disrupt activities) 7 - 13: Moderate pain (interferes significantly with focus, tasks, or sleep) 14 - 20: Severe / Worst imaginable pain (debilitating, unbearable)
Pain assessment using Verbal Rating Scale (VRS-4)
时间窗: 12 to 72 hours post surgery
A rating scale used to assess pain by score rated from 0-3 where; 0 = None (No pain) 1. = Mild 2. = Moderate 3. = Severe
次要结局
- Patient reported Postoperative swelling using NRS-21(12-72 hours post surgery)
- Swelling rating using VRS-4(12 to 72 hours post surgically)
- Number of patient reported analgesics post surgery(12 - 72 hours post surgery)
研究者
Mostafa Shehabeldin
Assistant Professor
The University of Texas Health Science Center at San Antonio