Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Immediate Post-procedure Pain Score
研究概览
简要总结
The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on immediate post-procedural pain scores in patients undergoing first trimester suction curettage with local anesthesia only.
Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately after the procedure.
Secondary hypotheses include:
- Pain scores on the 21-point scale will also be significantly lower in the ketorolac group immediately after cervical dilation and 15 minutes post-procedure.
- Fewer patients in the ketorolac group will rate their pain as "severe" on a subjective pain rating scale.
- Patients in the ketorolac group will be more satisfied with their pain control.
- Side effects will be similar between groups.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age 18 or older seeking suction curettage at Planned Parenthood League of Massachusetts (PPLM)
- •Gestational age less than or equal to 11+6, confirmed by ultrasound
- •Eligible for suction curettage according to PPLM protocols
- •Choice of local anesthesia
排除标准
- •Choice of IV sedation for pain control
- •Hypersensitivity to NSAIDs or lidocaine
- •Contraindications to NSAIDs:
- •Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term NSAID or aspirin use Bleeding disorder
- •NSAIDs taken < 8 hours prior to procedure
- •Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
- •Long-term narcotic use
- •Unable or unwilling to complete required study procedures
- •Previous participation in the study
研究组 & 干预措施
Ketorolac
Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)
干预措施: Ketorolac (Drug)
Ibuprofen
Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Immediate Post-procedure Pain Score
时间窗: Immediately (within 1 minute) after suction and speculum removal
The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five). This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009).
次要结局
- Pain Scores 15 Minutes Post-procedure(Fifteen minutes after the procedure)
- Pain Scores Immediately After Cervical Dilation(Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula)