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

Participants will have the standard MRI of the brain that is performed for radiation planning for brain tumors.
Addition of the additional MRI sequences to the standard MRI before radiation therapy. This typically adds 10-15 minutes to the length of the scan.
An additional MRI scan to be scheduled during one of the final five radiation treatment days that would not otherwise occur. There will be no contrast injection as part of this second scan. This may typically take 40-45 minutes.
Collection of information about participants' tumor, including copies of their MRIs and later outcome of treatment.

Gliosarcoma

Glioma

APT MRI

The SKCCC at Johns Hopkins

Pilot Study Using Amide Proton Transfer Magnetic Resonance Imaging Distinguishing Glioma

A Pilot Study Using Amide Proton Transfer (APT) Magnetic Resonance Imaging to Distinguish Tumor Bearing Cancerous Tissue From Normal Tissue in Patients With Glioma.

Difference in radiation target volumes between standard MRI and Amide Proton Transfer (APT) imaging.

Number of days from Day 23-28 (end of radiation) to tumor recurrence

Number of months from end of radiation therapy until death

Number of days to absolute change in voxels at the end of radiation treatment.

Change in voxels of APT and DWI signal or pattern during the course of radiation treatment assessed at 3 years or until death, whichever occurs first.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Subjects receive only one injection of NeoSTX in saline on the back of one calf (test side). Subjects receive NeoSTX in saline in subsequent dose escalation levels: 5mcg, 10mcg, 15mcg, 20mcg, 30mcg, and 40mcg NeoSTX.

Subjects receive only one injection of NeoSTX in combination with 0.2% bupivacaine on the back of one calf (test side). Subjects receive NeoSTX in bupivacaine in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg NeoSTX.

Subjects receive one injection of NeoSTX in bupivacaine 0.2% with epinephrine 5 mcg/ml on the back of one calf (test side). Subjects receive NeoSTX in bupivacaine 0.2% with epinephrine 5 mcg/ml in doses of 10 mcg or 30 mcg of NeoSTX.

Subjects receive one injection of saline on the back of one calf (test side).

Safety of Neosaxitoxin in Healthy Volunteers

NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% alone on one side (control). On the other side they receive NeoSTX in saline (test). Subjects receive NeoSTX in saline in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.

Neosaxitoxin in saline

NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX with 0.2% bupivacaine. Subjects receive NeoSTX in 0.2% bupivacaine in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.

NeoSTX + bupivacaine 0.2%

Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml. Subjects receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml in doses of 10 mcg or 30 mcg of NeoSTX.

NeoSTX + bupivacaine 0.2% + epinephrine 5mcg/ml

Each subject receives one injection with bupivacaine 0.2% alone on one side. On the other side they receive saline placebo.

Saline placebo

Boston Children's Hospital

Safety Study of Long-Acting Local Anesthetic

Neosaxitoxin (NeoSTX) Alone and in Combination With Bupivacaine as Prolonged Duration Local Anesthetics: A Phase I Investigator-initiated Dose Escalation Study

measured by noninvasive quantitative sensory testing (QST)

amide/edema

Combination Analgesia for Neonatal Circumcision

Pilot Study Using Amide Proton Transfer Magnetic Resonance Imaging Distinguishing Glioma

Safety Study of Long-Acting Local Anesthetic

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