Analgesic Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair; a Randomized, Double, Blinded, Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Opioid (Fentanyl and Morphine) Consumption
研究概览
简要总结
The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. The study will have three study groups based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine) alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 5 months to five years of age
- •ASA physical status I or II
- •primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (BMT), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.?
排除标准
- •Repeat/revision cleft palate repair
- •Contraindications to acetaminophen administration (liver or renal dysfunction, allergy)
- •Chronic pain medications
- •Diagnosis of chronic pain syndrome
- •Contraindications to morphine (renal impairment, allergy)
- •Seizure disorders and/or taking anti-seizure medications
- •Contraindications to oral midazolam (liver dysfunction, allergy)
- •Allergy to local anesthetics
研究组 & 干预措施
Ofirmev®
Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev® will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.
干预措施: Ofirmev® (Drug)
Oral acetaminophen
Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev® (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.
干预措施: Oral acetaminophen (Drug)
Opioid only
This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.
干预措施: Opioid only (Drug)
结局指标
主要结局
Opioid (Fentanyl and Morphine) Consumption
时间窗: intraoperative period and first postoperative 24 hours
The primary outcome measure of the study will be to measure opioid (Fentanyl and Morphine) consumption during the intraoperative period first postoperative 24 hours (measured in morphine equivalents).
次要结局
未报告次要终点