"Does a 1 Plus 1 Hydromorphone Pain Protocol Have a Similar Rate of Respiratory Depression to Physician Discretion Protocol in a Geriatric Population With Moderate to Severe Pain?"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Respiratory Depression
研究概览
简要总结
This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of moderate to sever pain in the Emergency Department. Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be enrolled in one of two study arms, "1+1" versus usual care group. 1+1 patients will receive 1mg hydromorphone followed by another 1mg after 15 minutes if pain persists. Usual care group patients will have pain treated per the discretion of the attending physician. Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression.
详细描述
This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of long bone fractures in the Emergency Department. Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be screened and randomized to one of two study arms, "1+1" versus usual care group. Neither the research associate, nurse, or attending physician will be blinded to the patients randomization. Patient pain score will be assessed at baseline using VAS score. "1+1" patients will receive 1mg hydromorphone at "timepoint 0" (baseline) followed by another 1mg after 15 minutes (along with repeat VAS pain score) if the patient answers "yes" to "Do you need more pain medicine?" At 60 minutes, patient pain will be assessed a final time and if patient needs more pain medicine, additional treatment will be dictated by physician discretion. Usual care group patients will also have VAS pain scores assessed at timepoint 0, 15 and 60 minutes and will have pain treated per the discretion of the attending physician. Patients will be placed on capnometer for continuous monitoring of respiratory status to guard against any opioid induced respiratory depression. Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression. We propose that the "1+1" hydromorphone protocol is easy to implement, as it includes a set timeline, a standard question, and a set dosage of a potent analgesic. We hypothesize that it will provide adequate analgesia in the majority of patients without causing the anticipated level of respiratory depression.
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
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient who presents a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia
- •Able to provide consent.
排除标准
- •Patient or family member unable to consent
- •Altered mental status
- •SpO2 less than 95 percent
- •Allergy to opiates
- •Hypotension (Systolic blood pressure less than 90 mmHg)
- •Chronic oxygen dependency or known CO2 retention
- •Acute ETOH or drug intoxication
- •History of chronic pain syndrome or chronic use of opiate narcotics
- •History of opiate/heroin addiction, past or current.
- •End stage renal disease/dialysis patient
- •Chronic metabolic acidosis
- •Physician feels that patient would be poor candidate for study
- •Weight less than 100 pounds, all patients will be weighted
- •Patients younger than 60 years of age
研究组 & 干预措施
1mg + 1mg Hydromorphone
Patient will receive 1 mg of hydromorphone for pain at timepoint 0. After 15 minutes, patients will be asked if the still need pain medication. If yes, patients will immediately receive 1mg hydromorphone. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.
干预措施: Hydromorphone (Drug)
Usual Care Group
Patient will receive pain medicine per doctor's discretion at timepoint 0. After 15 minutes, patients will be asked if they still need pain medication. If yes, physicians will not be notified and patient will continue to have pain managed as deemed necessary by physician per "usual care." Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.
干预措施: Usual care group (Drug)
结局指标
主要结局
Respiratory Depression
时间窗: From administration of drug (time 0 minutes) to end of study (60 minute mark)
Incidence of respiratory depression (defined as a ETCO2 of 50 mmHg or greater, a 10% change from baseline, or loss of waveform for 15 seconds or greater)
次要结局
- Successful Treatment of Patient Pain(15 min and 60 min after baseline)
- Change in VAS Score(15 min and 60 min after baseline)
- Hypotension(Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark))
- Allergic Reaction to Study Drug(From administration of drug (time 0 minutes) to end of study (60 minute mark))
- Hypoxia(From administration of drug (time 0 minutes) to end of study (60 minute mark))
- Serious Adverse Events(From administration of drug (time 0 minutes) to end of study (60 minute mark))