Combination Analgesia for Neonatal Circumcision

NCT02990364 | Completed Phase 3 DMC

• 1 other identifier: SUR.YE.01
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Analgesia

Keywords

Circumcision; Analgesia; Controlled Clinical Trial

Outcome Measures

Primary Outcomes (1)

• The Neonatal Infant Pain Scale (NIPS)

  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.

  During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation

Secondary Outcomes (3)

• Heart Rate

  During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation

• Crying Time

  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

Study Arms (4)

Control: EMLA Topical Product

ACTIVE COMPARATOR

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.

Drug: EMLA Topical Product

EMLA + Sucrose

ACTIVE COMPARATOR

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.

Drug: Sucrose; Drug: EMLA Topical Product

EMLA + Sucrose + Ring Block

ACTIVE COMPARATOR

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.

Drug: Sucrose; Drug: Lidocaine; Drug: EMLA Topical Product

EMLA + Sucrose + DPNB

ACTIVE COMPARATOR

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.

Drug: Sucrose; Drug: Lidocaine; Drug: EMLA Topical Product

Interventions

Sucrose DRUG

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

Also known as: 25% Sucrose

EMLA + Sucrose; EMLA + Sucrose + DPNB; EMLA + Sucrose + Ring Block

Lidocaine DRUG

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.

Also known as: Xylocaine and Lignocaine

EMLA + Sucrose + DPNB; EMLA + Sucrose + Ring Block

EMLA Topical Product DRUG

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

Also known as: Eutectic Mixture of Local Anesthetics

Control: EMLA Topical Product; EMLA + Sucrose; EMLA + Sucrose + DPNB; EMLA + Sucrose + Ring Block

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Unhealthy, premature males.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

MeSH Terms

Conditions

Agnosia

Interventions

Sucrose; Lidocaine; Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Prilocaine; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Pediatric Critical Care

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share