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.

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.

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.

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.

Analgesia

Sucrose was given to three out of the 4 intervention groups, to assess its effectiveness in managing pain during circumcision.

Sucrose

Lidocaine was given as a local anesthetic via Ring and Dorsal Penile Block to two of the intervention groups, in combination with the topical cream EMLA and sucking on sucrose.

Lidocaine

EMLA cream will be applied 70 minutes to the circumcision to all participants of the study.

EMLA Topical Product

Combination Analgesia for Neonatal Circumcision

Analgesia for Neonatal Circumcision: A Randomized Controlled Clinical Trial of EMLA Versus Combination of EMLA, Sucrose and Dorsal Penile Nerve Block or Ring Block

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:
Facial Expression
Cry
Breathing Pattern
Arms
Legs *
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.

Effects on heart rate, measured by beats/minute

Crying time, measured in seconds using a stop watch.

IPD will not be shared with researchers outside the scope of the approved list by the Institutional Review Board of the American University of Beirut.
Only aggregate and de-identified data will be shared.

Rana Sharara

Assistant Professor of Pediatrics and Pediatric Critical Care

American University of Beirut Medical Center

Neither donors or recipients will receive NO

Donor will not receive NO, recipient will receive up to 48 hours of NO

The donor will receive NO for 3 hours and the recipient will receive NO for up to 48 hours

Lung Transplantation

Nitric oxide

inhalation; 10ppm; 3 hours (donor) up to 48 hours (recipient)

Hospital General La Fe

Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation

A Pilot, Single Center Prospective, With Parallel Groups, Controlled and Open to Evaluate the Efficacy of Nitric Oxide for Inhalation in Lung Donors and in the Prevention of Reperfusion Injury.

methemoglobinemia/oedeem

Combination Analgesia for Neonatal Circumcision

Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation

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