Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Follow up rate
研究概览
简要总结
The goal of this pilot randomized clinical trial is to determine the effect of the addition of IV acetaminophen to opioid-based pain regimes for infants admitted to the neonatal intensive care unit (NICU) after surgery.
This is a pilot trial; the main goals are to make sure our study methods work before performing a larger study.
The main clinical aims are:
- Determine if adding IV acetaminophen reduces pain
- Determine if adding IV acetaminophen reduces opioid use
- Determine if adding IV acetaminophen reduces complications
Participants will be randomized to two groups:
Comparator: Fentanyl and IV acetaminophen Control: Fentanyl and placebo
Patients will receive either IV acetaminophen or placebo at regular intervals for seven days after surgery. Patients will be followed daily during that period. Charts will be reviewed at 90-days for final outcomes.
详细描述
Purpose: Opioid use in neonates is associated with short and long-term adverse events. Multi-modal pain control offers the ability to control pain while reducing opioid exposure. This topic has been relatively unexamined in preterm and term neonates. Specifically, this trial aims to evaluate the effect of adding IV acetaminophen to standard opioid-based pain regimes in neonates in the neonatal intensive care unit (NICU) undergoing major abdominal and thoracic surgery.
Objectives: The primary aim of the proposed study is to determine the feasibility and cost of conducting a multicenter, randomized control trial to compare the efficacy of IV acetaminophen and fentanyl, to fentanyl and saline placebo, in terms of reduction of postoperative pain, opioid use, adverse events. The primary outcome is feasibility; secondarily, efficacy and safety will be assessed.
Design: This single-center, parallel-arm, placebo-controlled, fully blinded, randomized controlled external feasibility trial will enroll patients admitted in the neonatal intensive care unit (NICU) who have undergone major, thoracic, or abdominal surgery. Patients will be randomized 1:1, with parallel allocation to receive acetaminophen and fentanyl or fentanyl and saline placebo. All study staff, clinical staff and guardians will be blinded. As this is a pilot study, no sample size will be calculated, however; we aim to enroll 60 patients. A sample size calculation will be completed for the full RCT if it is deemed feasible from the results of this study. Patients will be followed for the day of surgery and the following 7 postoperative days (192 hours) and have their charts reviewed at 90 days.
Impact: The results of this study will be used to determine the feasibility of conducting a multi-center RCT to assess the effect of IV acetaminophen on fentanyl infusions in postoperative neonatal patients. The effect of IV acetaminophen for postoperative pain in preterm neonates has yet to be studied, this trial would generate novel insights into its efficacy. The prolonged follow-up period would also provide novel insights into recovery throughout the entire perioperative period.
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)
盲法说明
IV acetaminophen and saline appear identical in solution. They will be administered at identical rates. Care providers, participants' parents, investigators, outcomes assessors, and statisticians will remain blinded.
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates, admitted to McMaster Children's Hospital NICU
- •Has had major open, thoracic or abdominal surgery (see appendix 1, table 6).
- •Informed consent obtained from guardian(s)
排除标准
- •Hepatic dysfunction
- •AST, ALT or Bilirubin > 3x upper limit of normal
- •INR ≥ 3.0 or PT greater than 20s regardless of vitamin K administration
- •Renal dysfunction
- •Increase in serum creatinine ≥ 2x baseline (baseline: lowest value in first 5 days of hospitalization)
- •Urine output < 0.5 mL/kg/h for ≥ 12h
- •Allergy or intolerance to acetaminophen or fentanyl
- •Acetaminophen administration within 24 hours of the end of surgery
- •Nerve blocks or epidurals
- •Refusal or withdrawal of consent
- •Enrolment in another competing trial
- •No later than 12 hours after the end of surgery
- •12 months post gestational age or greater in age
- •Birthweight greater or equal to 2,500g.
- •Discharged from the McMaster NICU
研究组 & 干预措施
Comparator
Standard of care + IV acetaminophen:
Baseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of IV acetaminophen every 4 or 6 hours at weight-appropriate doses based on the patient's gestational age.
干预措施: Acetaminophen (Drug)
Placebo
Standard of care + placebo:
Baseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of an IV saline placebo every 4 or 6 hours at a rate which would mimic their dose of acetaminophen.
干预措施: Placebo (Drug)
结局指标
主要结局
Follow up rate
时间窗: 90 days
Number of patients followed in completion from postoperative day 0 to 7
Medication compliance
时间窗: 7 days
Number of patients who received at least 80% of doses of study drugs at the correct dose and interval
Recruitment rate
时间窗: through study completion, an average of 1.5 years
Mean number of patients randomized per month
Blinding index
时间窗: 7 days
Responses of nurse's physician's, and research staff's guess of group assignment (control vs treatment) compared to actual group assignment
次要结局
- Non-invasive ventilation(90 days)
- Enteral feeds(90 days)
- Glycerin suppository use(90 days)
- Daily fentanyl consumption(daily for 7 days)
- Total fentanyl consumption(7 days)
- Daily Consumption of other analgesics(daily for 7 days)
- Invasive ventilation(90 days)
- Bowel movement(90 days)
- Postoperative Pain(every 6 hours for entire study period (7 days after surgery))
- Length of stay(90 days)
- Total consumption of other analgesics(7 days)
研究者
Victoria Archer
Resident Principal Investigator
McMaster Children's Hospital