A Randomized Blinded Placebo Controlled Trial Assessing Ketorolac (Toradol) at Oocyte Retrieval
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Administration of IV narcotic for rescue analgesia during recovery in the post anesthesia care unit (PACU)
研究概览
简要总结
To determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.
详细描述
Postoperative pain control is an essential component to any surgical procedure. Surgery represents a time during which opioid-naïve patients may be exposed to narcotics, risking opioid related complications and future opioid-use disorder. Approximately 150,000 oocyte retrievals are performed per year in the United States, according to the 2017 Assisted Reproductive Technology National Summary Report. A reduction in exposure to narcotics in this field has significant public health implications, particularly given that approximately 6% of new persistent opioid use occurs following minor surgical procedures.
Ketorolac (Toradol) has been demonstrated to be a safe and efficacious agent to achieve pain control postoperatively with no significant increase in adverse events.
The purpose of this prospective randomized blinded placebo controlled trial is to determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.
Approximately 400 women (n=200 in each arm) will be enrolled according to the inclusion/exclusion criteria among patients of Shady Grove Fertility. Participants will undergo a standard in vitro fertilization cycle (IVF) followed by egg retrieval (ER). Participants will be randomized to receive either IV ketorolac or IV placebo at the conclusion of the egg retrieval, administered by the anesthesia provider. All enrolled patients will receive standard post-operative pain management. The investigational component of this study lies in assessing post-operative pain control in the immediate post-operative period and in the post-operative period after discharge as reflected by pain scores and narcotic medication usage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Allocation group will not be disclosed to the patient or the physician or the nurse or the outcome assessor. The anesthesia provider administering the IV Ketorolac or Placebo will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Females over 18 years of age who are scheduled to undergo oocyte retrieval
- •Patients must be able to read and understand written English or have an appropriate certified medical translator available.
- •Standard eligibility criteria to undergo IVF and embryo transfer at Shady Grove
排除标准
- •Known allergy to ketorolac
- •Those with known medical conditions precluding them from ketorolac use (active peptic ulcer disease, recent or history of hemorrhage or perforation, known renal or hepatic insufficiency, suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, bleeding disorders, recent myocardial infarction, or stroke.)
- •BMI ≥ 40 kg/m2
- •History of substance abuse
- •Chronic opioid use
- •Transabdominal oocyte retrieval
研究组 & 干预措施
Standard post-operative pain management + Ketorolac (Toradol)
Subject will undergo an IVF cycle with ovarian hyperstimulation and oocyte retrieval. Standard protocols will be used for both study groups and involve administration of gonadotropins to stimulate ovarian follicle growth and regular monitoring with ultrasound and serum estradiol and progesterone levels until follicles reach a desired size. Human Chorionic Gonadotropin (HCG) or leuprolide acetate will be administered to trigger final oocyte maturation prior to oocyte retrieval under anesthesia. On the day of oocyte retrieval, the anesthesia provider will provide syringes of IV ketorolac (30 mg if ≥50 kg or 15 mg if <50 kg per manufacturer dosing) or IV placebo (saline). If assigned to the study arm, IV ketorolac will be administered by the anesthesia provider. All enrolled patients will receive standard post-operative pain management. Patients will be contacted post-operatively, to access pain scores and record the amount of the prescribed narcotic medications utilized since discharge.
干预措施: Ketorolac (Toradol) (Drug)
Standard post-operative pain management + Placebo (saline)
Subject will undergo an IVF cycle with ovarian hyperstimulation and oocyte retrieval. Standard protocols will be used for both study groups and involve administration of gonadotropins to stimulate ovarian follicle growth and regular monitoring with ultrasound and serum estradiol and progesterone levels until follicles reach a desired size. HCG or leuprolide acetate will be administered to trigger final oocyte maturation prior to oocyte retrieval under anesthesia. On the day of oocyte retrieval, the anesthesia provider will provide syringes of IV ketorolac (30 mg if ≥50 kg or 15 mg if <50 kg per manufacturer dosing) or IV placebo (saline). If assigned to the control arm, IV placebo (saline) will be administered by the anesthesia provider. All enrolled patients will receive standard post-operative pain management. Patients will be contacted post-operatively, to access pain scores and record the amount of the prescribed narcotic medications utilized since discharge.
干预措施: Placebo (saline) (Other)
结局指标
主要结局
Administration of IV narcotic for rescue analgesia during recovery in the post anesthesia care unit (PACU)
时间窗: Oocyte retrieval procedure day
The primary objective is to evaluate the use of ketorolac as a safe and effective analgesic after transvaginal oocyte retrieval (TVOR) by assessing the number of patients requiring additional analgesia with IV narcotic during recovery in the post anesthesia care unit (PACU).
次要结局
- Dose of narcotic for rescue analgesia during recovery in the PACU(Oocyte retrieval procedure day)
- Incidence of complications and adverse events(From oocyte retrieval procedure day up to 1 week post oocyte retrieval)
- Intensity of pain in PACU(Oocyte retrieval procedure day)
- Biochemical pregnancy rate for patients who proceed to a fresh embryo transfer.(From date of randomization until ~10 days following embryo transfer)
- Type of narcotic for rescue analgesia during recovery in the PACU(Oocyte retrieval procedure day)
- Intensity of pain at baseline(Oocyte retrieval procedure day)
- Intensity of pain after discharge(From oocyte retrieval procedure day up to 1 week post oocyte retrieval)
- Home narcotic use(From oocyte retrieval procedure day up to 1 week post oocyte retrieval)
- Clinical pregnancy rate for patients who proceed to a fresh embryo transfer.(From date of randomization until 5-8 weeks estimated gestational age)
- Implantation rate for patients who proceed to a fresh embryo transfer.(From date of randomization until 7-8 weeks estimated gestational age)
- Ongoing implantation rate for patients who proceed to a fresh embryo transfer.(From date of randomization until 7-8 weeks estimated gestational age)
- Pregnancy loss rate for patients who proceed to a fresh embryo transfer.(From date of randomization until pregnancy loss, assessed up to 11 months)
- Live birth rate for patients who proceed to a fresh embryo transfer.(From date of randomization until live born infant at an estimated gestational age of at least 23 weeks or greater, assessed up to 11 months)