AnalgesiaPhase 3NCT02990364
Combination Analgesia for Neonatal Circumcision
A Phase 3 study testing Sucrose, Lidocaine and EMLA Topical Product in people with Analgesia, run by American University of Beirut Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 3 days, men onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Sucrose, Lidocaine and EMLA Topical Product
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Unhealthy, premature males.
About this study
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
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.
Read the detailed description
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):
Dorsal penile nerve block is an anesthetic technique first described in 1978, and has since then been extensively evaluated in the management of pain during circumcision. 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. Five minutes after the block the circumcision will be performed.
Ring Block:
Ring block is another anesthetic technique described in the 1990s that has also been examined for pain control during circumcision. 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 circumcising physician. Five minutes later the circumcision will be performed.
Intervention groups:
Control group: (1) EMLA Combination Groups: (2) EMLA + Sucrose (3) EMLA + Ring Block + Sucrose; (4) EMLA + Sucrose + DPNB For all groups the same procedures detailed above for EMLA, DPNB, and ring block will be followed depending on patient grouping.
General:
EMLA will be used on all patients.
Videotaping:
In order to ensure that the study is properly blinded, video-taping of the procedure will need to take place. A video camera will be set to capture the infant's face and torso and the monitor, but not the individual performing the circumcision. The videos will be labeled numerically, and not by patient name. Videos will be viewed by two other individuals (not present at the circumcision itself and not responsible for obtaining consent), and a possible third viewer may be required to resolve conflicting opinions. The video tapes will not be seen by any other individual, and will only be for data collection and pain scoring. They will be kept in the possession of the two principal investigators in a locked drawer in their offices at all times. The video tapes will be destroyed after the completion of the study.
Outcomes:
The primary outcome variable will be the pain score. Pain scores consist of behavioral components of the infant such as facial expression, crying, breathing patterns, arm movement, and leg movement. Secondary outcomes will include effects on heart rate, crying time, and oxygen saturation (obtained from the monitor).
Patients' participation can be ended at any time by the investigator. Significant new findings will be conveyed to the parents of the newborn.
Risks
The main risks of participation in the study are:
- the adverse effects that might result from circumcision itself, such as pain, bleeding, surgical trauma, local infections, and meatal stenosis.
- adverse effects that may result from drugs, such as allergic reactions
- adverse effects that might result from specific drug administration technique, EMLA may result in methemoglobinemia and local skin reactions such as blanching, edema, and erythema. DPNB and ring block may result in bruising, bleeding, and hematomas at the injection site.
- adverse effects if the anesthetic is erroneously injected systemically.
Although the investigators have taken steps to minimize the risks of this study, there may also be unforeseeable risks.The parents may choose to withdraw consent at any time during the study.
Benefits All the anesthetics that will be used in the study have already been shown to play a role in pain reduction during circumcision, however some seem to be more effective than others. The participating child will directly benefit from the study, since his pain will be controlled to some extent during the circumcision procedure. Furthermore, if the study provides conclusive evidence about the most effective method of analgesia, then guidelines can be instituted so that in the future all newborns will have their pain successfully controlled during the procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseDrug
Also called 25% Sucrose
Sucrose was given to three out of the 4 intervention groups, to assess its effectiveness in managing pain during circumcision.
LidocaineDrug
Also called Xylocaine and Lignocaine
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.
EMLA Topical ProductDrug
Also called Eutectic Mixture of Local Anesthetics
EMLA cream will be applied 70 minutes to the circumcision to all participants of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Sucrose; Drug: Lidocaine; Drug: EMLA Topical Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
Secondary outcomes (3)
Heart Rate
Effects on heart rate, measured by beats/minute
Measured: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
Crying Time
Crying time, measured in seconds using a stop watch.
Measured: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
Oxygen Saturation
Oxygen Saturation measured in percent
Measured: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Sharara, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990364
- Sponsor's protocol ID
- SUR.YE.01
- Status last verified
- Jun 2017
- First submitted
- 6 Dec 2016
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02990364
- Acronym / sponsor ID
- SUR.YE.01
- Conditions
- Analgesia
- Keywords
- Circumcision, Analgesia, Controlled Clinical Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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):
Dorsal penile nerve block is an anesthetic technique first described in 1978, and has since then been extensively evaluated in the management of pain during circumcision. 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. Five minutes after the block the circumcision will be performed.
Ring Block:
Ring block is another anesthetic technique described in the 1990s that has also been examined for pain control during circumcision. 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 circumcising physician. Five minutes later the circumcision will be performed.
Intervention groups:
Control group: (1) EMLA Combination Groups: (2) EMLA + Sucrose (3) EMLA + Ring Block + Sucrose; (4) EMLA + Sucrose + DPNB For all groups the same procedures detailed above for EMLA, DPNB, and ring block will be followed depending on patient grouping.
General:
EMLA will be used on all patients.
Videotaping:
In order to ensure that the study is properly blinded, video-taping of the procedure will need to take place. A video camera will be set to capture the infant's face and torso and the monitor, but not the individual performing the circumcision. The videos will be labeled numerically, and not by patient name. Videos will be viewed by two other individuals (not present at the circumcision itself and not responsible for obtaining consent), and a possible third viewer may be required to resolve conflicting opinions. The video tapes will not be seen by any other individual, and will only be for data collection and pain scoring. They will be kept in the possession of the two principal investigators in a locked drawer in their offices at all times. The video tapes will be destroyed after the completion of the study.
Outcomes:
The primary outcome variable will be the pain score. Pain scores consist of behavioral components of the infant such as facial expression, crying, breathing patterns, arm movement, and leg movement. Secondary outcomes will include effects on heart rate, crying time, and oxygen saturation (obtained from the monitor).
Patients' participation can be ended at any time by the investigator. Significant new findings will be conveyed to the parents of the newborn.
Risks
The main risks of participation in the study are:
- the adverse effects that might result from circumcision itself, such as pain, bleeding, surgical trauma, local infections, and meatal stenosis.
- adverse effects that may result from drugs, such as allergic reactions
- adverse effects that might result from specific drug administration technique, EMLA may result in methemoglobinemia and local skin reactions such as blanching, edema, and erythema. DPNB and ring block may result in bruising, bleeding, and hematomas at the injection site.
- adverse effects if the anesthetic is erroneously injected systemically.
Although the investigators have taken steps to minimize the risks of this study, there may also be unforeseeable risks.The parents may choose to withdraw consent at any time during the study.
Benefits All the anesthetics that will be used in the study have already been shown to play a role in pain reduction during circumcision, however some seem to be more effective than others. The participating child will directly benefit from the study, since his pain will be controlled to some extent during the circumcision procedure. Furthermore, if the study provides conclusive evidence about the most effective method of analgesia, then guidelines can be instituted so that in the future all newborns will have their pain successfully controlled during the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control: EMLA Topical Product | Active comparator | Drug: EMLA Topical ProductThis 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. |
| EMLA + Sucrose | Active comparator | Drug: Sucrose, Drug: EMLA Topical ProductThere 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. |
| EMLA + Sucrose + Ring Block | Active comparator | Drug: Sucrose, Drug: Lidocaine, Drug: EMLA Topical ProductRing 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. |
| EMLA + Sucrose + DPNB | Active comparator | Drug: Sucrose, Drug: Lidocaine, Drug: EMLA Topical ProductDorsal 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. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Unhealthy, premature males.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SucroseAlso: 25% SucroseSucrose was given to three out of the 4 intervention groups, to assess its effectiveness in managing pain during circumcision. | Drug | EMLA + Sucrose, EMLA + Sucrose + DPNB, EMLA + Sucrose + Ring Block |
| LidocaineAlso: Xylocaine and LignocaineLidocaine 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. | Drug | EMLA + Sucrose + DPNB, EMLA + Sucrose + Ring Block |
| EMLA Topical ProductAlso: Eutectic Mixture of Local AnestheticsEMLA cream will be applied 70 minutes to the circumcision to all participants of the study. | Drug | Control: EMLA Topical Product, EMLA + Sucrose, EMLA + Sucrose + DPNB, EMLA + Sucrose + Ring Block |
Primary outcome
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.
3 secondary outcomes
Heart Rate
Time frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
Crying Time
Time frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
Oxygen Saturation
Time frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sucrose, Lidocaine and EMLA Topical Product in people with Analgesia, run by American University of Beirut Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Neonatal Infant Pain Scale (NIPS) (time frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017; AzTrials last refreshed its copy on 1 Nov 2026.