Analgesia for Neonatal Circumcision: A Randomized Controlled Clinical Trial of EMLA Versus Combination of EMLA, Sucrose and Dorsal Penile Nerve Block or Ring Block
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- The Neonatal Infant Pain Scale (NIPS)
研究概览
简要总结
Circumcision is a commonly performed procedure on newborn males. Clear recommendations and/or guidelines for pain control during the procedure do not exist. The purpose of this research is to compare various forms of analgesia to evaluate which is the more effective for pain reduction. The investigators hope that this study can provide definitive guidelines on the best form of analgesia to use during circumcision. It is important that we perform this study to ensure that in the future newborns' pain during circumcision is effectively managed.
详细描述
Procedure/Interventions/Drugs Several forms of analgesia, including local anesthetic creams or local anesthetics administered by injection, will be compared as methods of pain control during circumcision. All of these analgesics have already been used for intra-operative pain control during circumcision. The drugs that will be used in the study are all local anesthetics of the amino-amide group, and include lidocaine and prilocaine. Because there is no consensus on the best anesthetic for circumcision, the investigators propose a comparative study. Children taking part in this research will be put into groups which are selected by chance. There will be three different groups. One of the groups will serve as a control group, and in the three other groups combinations of anesthetics will be tested. The control group will be receiving the usual anesthetic used in the normal nursery for pain control during circumcision, while the combination groups will be receiving additional anesthetic agents. Randomization to groups will be done using a random sequence generator. The intervention for each patient will then be placed in a sealed envelope, and will be opened by the individual performing the circumcision at the time the procedure is scheduled.
The following interventions will be used:
EMLA Topical Product:
EMLA cream is a eutectic mixture of 2.5% lidocaine and 2.5% prilocaine, used as a topical anaesthetic to diminish pain from cutaneous procedures. Seventy minutes prior to circumcision, the newborn will be placed in the circumcision mold with the legs restrained, and attached to a monitor. 1 gram of EMLA cream will be applied by the nurse to the penis using a syringe and then wrapped with a dressing (Tegaderm). After sixty minutes they will be returned to the circumstrep, reattached to the monitor, and legs will be restrained. The Tegaderm and drug will be removed, and the infant will be left to settle then the circumcision will take place.
Dorsal Penile Nerve Block (DPNB):
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, term, newborn males with a gestational age of 37 weeks or more admitted to the newborn nursery at the American University of Beirut Medical Center.
排除标准
- •Unhealthy, premature males.
研究组 & 干预措施
Control: EMLA Topical Product
This represents the control group and it is the traditional analgesic used for circumcisions.
EMLA cream is a eutectic mixture of 2.5% lidocaine and 2.5% prilocaine, used as a topical anaesthetic to diminish pain from cutaneous procedures. Seventy minutes prior to circumcision, the newborn will be placed in the circumcision mold with the legs restrained, and attached to a monitor. 1 gram of EMLA cream will be applied by the nurse to the penis using a syringe and then wrapped with a dressing (Tegaderm). After sixty minutes the Tegaderm and drug will be removed, and the infant will be left to settle until the circumcision.
干预措施: EMLA Topical Product (Drug)
EMLA + Sucrose
There is high-quality evidence for the beneficial effect of sucrose (24%) with non-nutritive sucking (pacifier dipped in sucrose) or 0.5 mL of sucrose orally in preterm and term infants. To assess this, 10 ml of sucrose (24%) will be given to the infant during the course of the circumcision.
In combination to the EMLA cream, the infant will be given sucrose during the circumcision to test the effects of sucrose and sucking on pain management.
干预措施: Sucrose (Drug)
EMLA + Sucrose
There is high-quality evidence for the beneficial effect of sucrose (24%) with non-nutritive sucking (pacifier dipped in sucrose) or 0.5 mL of sucrose orally in preterm and term infants. To assess this, 10 ml of sucrose (24%) will be given to the infant during the course of the circumcision.
In combination to the EMLA cream, the infant will be given sucrose during the circumcision to test the effects of sucrose and sucking on pain management.
干预措施: EMLA Topical Product (Drug)
EMLA + Sucrose + Ring Block
Ring block will be done with 1% lidocaine without epinephrine injected in a band around the penis halfway along the shaft. Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with the legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the ring block and will be injected in a band around the penis. The block will be done by the circumciser.
In combination with the ring block, EMLA + sucrose will be given during the circumcision.
干预措施: Sucrose (Drug)
EMLA + Sucrose + Ring Block
Ring block will be done with 1% lidocaine without epinephrine injected in a band around the penis halfway along the shaft. Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with the legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the ring block and will be injected in a band around the penis. The block will be done by the circumciser.
In combination with the ring block, EMLA + sucrose will be given during the circumcision.
干预措施: Lidocaine (Drug)
EMLA + Sucrose + Ring Block
Ring block will be done with 1% lidocaine without epinephrine injected in a band around the penis halfway along the shaft. Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with the legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the ring block and will be injected in a band around the penis. The block will be done by the circumciser.
In combination with the ring block, EMLA + sucrose will be given during the circumcision.
干预措施: EMLA Topical Product (Drug)
EMLA + Sucrose + DPNB
Dorsal penile nerve block (DPNB) will be done with 1% lidocaine without epinephrine injected at two sites at the base of the penis (2 and 10 o'clock). Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the block, and equal aliquots in milliliters will be injected at the two sites at the base of the penis. The block will be done by the circumciser.
In combination with the DPNB, EMLA + sucrose will be given during the circumcision.
干预措施: Sucrose (Drug)
EMLA + Sucrose + DPNB
Dorsal penile nerve block (DPNB) will be done with 1% lidocaine without epinephrine injected at two sites at the base of the penis (2 and 10 o'clock). Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the block, and equal aliquots in milliliters will be injected at the two sites at the base of the penis. The block will be done by the circumciser.
In combination with the DPNB, EMLA + sucrose will be given during the circumcision.
干预措施: Lidocaine (Drug)
EMLA + Sucrose + DPNB
Dorsal penile nerve block (DPNB) will be done with 1% lidocaine without epinephrine injected at two sites at the base of the penis (2 and 10 o'clock). Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the block, and equal aliquots in milliliters will be injected at the two sites at the base of the penis. The block will be done by the circumciser.
In combination with the DPNB, EMLA + sucrose will be given during the circumcision.
干预措施: EMLA Topical Product (Drug)
结局指标
主要结局
The Neonatal Infant Pain Scale (NIPS)
时间窗: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
The Neonatal Pain Scale (NIPS) is a behavioral assessment tool for measurement of pain in preterm and full-term neonates. This can be used to monitor a neonate before, during and, after a painful procedure such as venipuncture. It was developed at the Children's Hospital of eastern Ontario. Parameters: 1. Facial Expression 2. Cry 3. Breathing Pattern 4. Arms 5. Legs \* 6. State of arousal The Legs parameter was removed for this study, as the legs are not shown in the video and are tied to the circumcision table during the operation. Moreover, following the circumcision the infants are tucked in via blankets that restrict leg movement.
次要结局
- Crying Time(During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation)
- Heart Rate(During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation)
- Oxygen Saturation(During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation)
研究者
Rana Sharara
Assistant Professor of Pediatrics and Pediatric Critical Care
American University of Beirut Medical Center