Other Preterm InfantsPhase 1NCT02268968
Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal CPAP Continuous Positive Airway Pressure
A Phase 1 study testing Lidocaine 2% Gel in people with Other Preterm Infants, run by Mansoura University Children Hospital at 1 site in Egypt.
Trial summary
The main purpose of this study is to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Other Preterm Infants
- What is being tested?
- Lidocaine 2% Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 1
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants < 37 weeks gestation
- Admitted to NICU, Mansoura University Children's Hospital
- Respiratory distress requiring use of nasal CPAP
- Informed consent obtained
Who cannot join
- Serious, life-threatening malformations
- Use of sedation, analgesia in the preceding 72 hours
- Those who undergo any surgical intervention
- Those who undergo any painful procedures as venipuncture, intubation, suctioning, blood sampling, heel-prick, catheterization 30 minutes before assessment
- Those with signs of nasal injuries at the time of application of nCPAP
- Necrotizing enterocolitis
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit, Mansoura University Children Hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal Contiuous Positive Airway Pressure
The main purpose of this study is to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants
Read the detailed description
Preterm infants admitted to NICUs are exposed to a range of painful procedures. The exposure to pain during this critical of brain development may have adverse consequences. Application of nasal CPAP is one of the painful procedures. A consensus statement on neonatal pain made recommendations for analgesia for neonatal procedures. Topical lidocaine is frequently used as a topical anesthetic during venipuncture, heel lancing, circumcision, endotracheal intubations, nasogastric tube insertion, endoscopy and bronchoscopy. However, the use of topical lidocaine for its analgesic effect on application of nasal CPAP has not been evaluated.
This study proposes a randomized controlled trial to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants.
- Conditions
- Other Preterm Infants
- Being tested
- Lidocaine 2% Gel
- Keywords
- Topical Lidocaine, Nasal CPAP, Pain, Preterm Infants, Salivary cortisol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% GelDrug
Also called Xylocaine jelly 2%
Lidocaine 2% gel will be applied to nostrils and nasal CPAP prong 5 minutes prior to application of nasal CPAP
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Intervention: Topical lidocaine gel 2% (0.3 ml/kg) will be applied once only to the nostrils and nasal CPAP prong 5 minutes prior to the application of nasal CPAP Receives: Drug: Lidocaine 2% Gel |
| Control | No intervention | No topical lidocaine will be used prior to application of nasal CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Premature Infant Pain (PIPP) Scale
PIPP comprises 3 behavioral variables (time of brow bulge, eye squeeze, and naso-labial furrow), 2 physiologic variables (changes in heart rate and SpO2), and 2 contextual variables (gestational age and behavioral state). Behavioral state ranges from "active/awake, eyes open, facial movements" to "quiet/sleep, eyes closed, no facial movements." Every variable will be scored on a scale from 0 to 3. A total score the sum of total of points indicating: lack of pain (0-6), mild -moderate pain (6-12) and severe pain (above 12). PIPP has documented reliability and validity and have been used previously in several studies in neonates. PIPP score measurement will be based on video recording the infant for 45 seconds. Three different DVDs will be compiled with the sets in random order. Three different nurses from NICU will be recruited to evaluate the segments. They will not be informed of the nature of the study. All 3 nurses are trained in performing the PIPP.
Measured: Immediately after application of nasal CPAP (approx 5 min)
Secondary outcomes (4)
Salivary cortisol
Salivary samples will be obtained 30 minutes after application of nasal CPAP using sterile single channel 500 μl pipette (Dragon Laboratory Instruments Limited, Beijing 101318 China). After collection, the saliva wll be centrifuged, frozen and stored at -70°C. The samples will later analysed using ELISA technique; IBL kits (IBL International GmbH, Flughafenstr. 52A, 22335 Hamburg, Germany).
Measured: 30 minute after application of nasal CPAP
Duration of first cry
The duration of the first cry will be defined as audible distressed vocalizations with a continuous pattern before a quiet interval of 5 seconds soon after application of nasal CPAP
Measured: Immediately after application of nasal CPAP (approx 5 min)
Possible adverse effects to lidocaine
CNS side effects as irritability, nervousness, confusion, vomiting, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest.
Cardiovascular side effects: bradycardia, hypotension, and cardiovascular collapse, and cardiac arrest.
Allergic: urticaria, edema, or anaphylactic reactions
Measured: Within 72 hours of application of topical lidocaine gel
Nasal trauma
The nose of enrolled infants will be assessed for any sign of injury 24 hours after application of nasal CPAP
Measured: 24 hours after application of nasal CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Other Preterm InfantsStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Abdel-Hady, Mansoura University Children Hospital
- Investigators
- Hesham E Abdel-Hady, MD, PhD, Principal investigator, Mansoura University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268968
- Sponsor's protocol ID
- MS 012
- Status last verified
- Apr 2015
- First submitted
- 16 Oct 2014
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Britto CD, Rao Pn S, Nesargi S, Nair S, Rao S, Thilagavathy T, Ramesh A, Bhat S. PAIN--perception and assessment of painful procedures in the NICU. J Trop Pediatr. 2014 Dec;60(6):422-7. doi: 10.1093/tropej/fmu039. Epub 2014 Jul 21.
PubMed 25053125Prevention and management of pain and stress in the neonate. American Academy of Pediatrics. Committee on Fetus and Newborn. Committee on Drugs. Section on Anesthesiology. Section on Surgery. Canadian Paediatric Society. Fetus and Newborn Committee. Pediatrics. 2000 Feb;105(2):454-61.
PubMed 10654977Bendixen D, Halvorsen AC, Hjelt K, Flachs H. Lignocaine gel used for lubrication of intranasal and endotracheal tubes in premature neonates. Acta Paediatr. 1994 May;83(5):493-7. doi: 10.1111/j.1651-2227.1994.tb13065.x.
PubMed 8086725Lillieborg S, Otterbom I, Ahlen K. Topical anaesthesia in neonates, infants and children. Br J Anaesth. 2004 Mar;92(3):450; author reply 450-1. doi: 10.1093/bja/aeh522. No abstract available.
PubMed 14970141
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal Contiuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT02268968
- Acronym / sponsor ID
- MS 012
- Conditions
- Other Preterm Infants
- Keywords
- Topical Lidocaine, Nasal CPAP, Pain, Preterm Infants, Salivary cortisol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Oct 2014 (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.
The main purpose of this study is to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants
Detailed description
Preterm infants admitted to NICUs are exposed to a range of painful procedures. The exposure to pain during this critical of brain development may have adverse consequences. Application of nasal CPAP is one of the painful procedures. A consensus statement on neonatal pain made recommendations for analgesia for neonatal procedures. Topical lidocaine is frequently used as a topical anesthetic during venipuncture, heel lancing, circumcision, endotracheal intubations, nasogastric tube insertion, endoscopy and bronchoscopy. However, the use of topical lidocaine for its analgesic effect on application of nasal CPAP has not been evaluated.
This study proposes a randomized controlled trial to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine 2% GelIntervention: Topical lidocaine gel 2% (0.3 ml/kg) will be applied once only to the nostrils and nasal CPAP prong 5 minutes prior to the application of nasal CPAP |
| Control | No intervention | –No topical lidocaine will be used prior to application of nasal CPAP |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants < 37 weeks gestation
- Admitted to NICU, Mansoura University Children's Hospital
- Respiratory distress requiring use of nasal CPAP
- Informed consent obtained
Key exclusion criteria (6 listed)
- Serious, life-threatening malformations
- Use of sedation, analgesia in the preceding 72 hours
- Those who undergo any surgical intervention
- Those who undergo any painful procedures as venipuncture, intubation, suctioning, blood sampling, heel-prick, catheterization 30 minutes before assessment
- Those with signs of nasal injuries at the time of application of nCPAP
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 |
|---|---|---|
| Lidocaine 2% GelAlso: Xylocaine jelly 2%Lidocaine 2% gel will be applied to nostrils and nasal CPAP prong 5 minutes prior to application of nasal CPAP | Drug | Lidocaine |
Primary outcome
The Premature Infant Pain (PIPP) Scale
Time frame: Immediately after application of nasal CPAP (approx 5 min)
PIPP comprises 3 behavioral variables (time of brow bulge, eye squeeze, and naso-labial furrow), 2 physiologic variables (changes in heart rate and SpO2), and 2 contextual variables (gestational age and behavioral state). Behavioral state ranges from "active/awake, eyes open, facial movements" to "quiet/sleep, eyes closed, no facial movements." Every variable will be scored on a scale from 0 to 3. A total score the sum of total of points indicating: lack of pain (0-6), mild -moderate pain (6-12) and severe pain (above 12). PIPP has documented reliability and validity and have been used previously in several studies in neonates. PIPP score measurement will be based on video recording the infant for 45 seconds. Three different DVDs will be compiled with the sets in random order. Three different nurses from NICU will be recruited to evaluate the segments. They will not be informed of the nature of the study. All 3 nurses are trained in performing the PIPP.
4 secondary outcomes
Salivary cortisol
Time frame: 30 minute after application of nasal CPAP
Duration of first cry
Time frame: Immediately after application of nasal CPAP (approx 5 min)
Possible adverse effects to lidocaine
Time frame: Within 72 hours of application of topical lidocaine gel
Nasal trauma
Time frame: 24 hours after application of nasal CPAP
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 14 Apr 2015.
- Background: PubMed 25053125Britto CD, Rao Pn S, Nesargi S, Nair S, Rao S, Thilagavathy T, Ramesh A, Bhat S. PAIN--perception and assessment of painful procedures in the NICU. J Trop Pediatr. 2014 Dec;60(6):422-7. doi: 10.1093/tropej/fmu039. Epub 2014 Jul 21.
- Background: PubMed 10654977Prevention and management of pain and stress in the neonate. American Academy of Pediatrics. Committee on Fetus and Newborn. Committee on Drugs. Section on Anesthesiology. Section on Surgery. Canadian Paediatric Society. Fetus and Newborn Committee. Pediatrics. 2000 Feb;105(2):454-61.
- Background: PubMed 8086725Bendixen D, Halvorsen AC, Hjelt K, Flachs H. Lignocaine gel used for lubrication of intranasal and endotracheal tubes in premature neonates. Acta Paediatr. 1994 May;83(5):493-7. doi: 10.1111/j.1651-2227.1994.tb13065.x.
- Background: PubMed 14970141Lillieborg S, Otterbom I, Ahlen K. Topical anaesthesia in neonates, infants and children. Br J Anaesth. 2004 Mar;92(3):450; author reply 450-1. doi: 10.1093/bja/aeh522. No abstract available.
Related trials for Other Preterm Infants
Recruiting
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
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.
Hesham E Abdel-Hady, MD, PhD principal investigator
Mansoura University Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine 2% Gel in people with Other Preterm Infants, run by Mansoura University Children Hospital at 1 site in Egypt.
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 4 inclusion and 6 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Premature Infant Pain (PIPP) Scale (time frame: Immediately after application of nasal CPAP (approx 5 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02268968, which also lists 4 linked publications.
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 14 Apr 2015.