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Combination Analgesia for Neonatal Circumcision

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ClinicalTrials.gov Identifier: NCT02990364
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Rana Sharara, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Analgesia Drug: Sucrose Drug: Lidocaine Drug: EMLA Topical Product Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Analgesia for Neonatal Circumcision: A Randomized Controlled Clinical Trial of EMLA Versus Combination of EMLA, Sucrose and Dorsal Penile Nerve Block or Ring Block
Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Drug: EMLA Topical Product
EMLA cream will be applied 70 minutes to the circumcision to all participants of the study.
Other Name: Eutectic Mixture of Local Anesthetics

Active Comparator: 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.

Drug: Sucrose
Sucrose was given to three out of the 4 intervention groups, to assess its effectiveness in managing pain during circumcision.
Other Name: 25% Sucrose

Drug: EMLA Topical Product
EMLA cream will be applied 70 minutes to the circumcision to all participants of the study.
Other Name: Eutectic Mixture of Local Anesthetics

Active Comparator: 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.

Drug: Sucrose
Sucrose was given to three out of the 4 intervention groups, to assess its effectiveness in managing pain during circumcision.
Other Name: 25% Sucrose

Drug: Lidocaine
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.
Other Name: Xylocaine and Lignocaine

Drug: EMLA Topical Product
EMLA cream will be applied 70 minutes to the circumcision to all participants of the study.
Other Name: Eutectic Mixture of Local Anesthetics

Active Comparator: 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.

Drug: Sucrose
Sucrose was given to three out of the 4 intervention groups, to assess its effectiveness in managing pain during circumcision.
Other Name: 25% Sucrose

Drug: Lidocaine
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.
Other Name: Xylocaine and Lignocaine

Drug: EMLA Topical Product
EMLA cream will be applied 70 minutes to the circumcision to all participants of the study.
Other Name: Eutectic Mixture of Local Anesthetics




Primary Outcome Measures :
  1. The Neonatal Infant Pain Scale (NIPS) [ Time Frame: 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.



Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation ]
    Effects on heart rate, measured by beats/minute

  2. Crying Time [ Time Frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation ]
    Crying time, measured in seconds using a stop watch.

  3. Oxygen Saturation [ Time Frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation ]
    Oxygen Saturation measured in percent



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Unhealthy, premature males.

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Responsible Party: Rana Sharara, Assistant Professor of Pediatrics and Pediatric Critical Care, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02990364     History of Changes
Other Study ID Numbers: SUR.YE.01
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.

Keywords provided by Rana Sharara, American University of Beirut Medical Center:
Circumcision
Analgesia
Controlled Clinical Trial
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Lidocaine, Prilocaine Drug Combination
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined