Pain ManagementNCT06155825
Nonpharmacological Pain Management in Neonates
A study testing nonnutritive suckling, oral glucose 25% and facilitated tuckling in people with Pain Management and Neonates Pain Management, run by Assiut University.
Trial summary
This is A randomized controlled study which aim to: The primary aim in this study is assessment of non-pharmacological pain management in neonate and determine the most effective. The secondary aim of this study is to introduce idea of neonatal pain management. Read more about this study
- Who is it for?
- Ages 32 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Neonates Pain Management
- What is being tested?
- nonnutritive suckling, oral glucose 25% and facilitated tuckling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Feb 2025
- Phase
- Interventional
- 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 32 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy term newborn 32 week or more.
- Newborn during routine painful maneuvers as venipuncture and arterial puncture
Who cannot join
- 1) Preterm < 32 week 2) Newborn with neurological impairment 3) Sedated newborn 4) Newborn with metabolic diseases 5) Newborn with congenital anomalies 6) Newborn undergoing operative intervention
Trial locations and contacts
No sites are listed yet.
Safaa Mustafaa Abu Zaid, Resident of Pediatrics contact
About this study
Official title: Nonpharmacological Pain Management in Neonate (A Randomized Controlled Study)
This is A randomized controlled study which aim to:
The primary aim in this study is assessment of non-pharmacological pain management in neonate and determine the most effective.
Read more
The secondary aim of this study is to introduce idea of neonatal pain management. and record its effect on hospital stay and Duration to reach full enteral feeding. This prospective study will be conducted at NICU unit of Assiut University pediatrician hospital, Duration of study 1 year from 1/12/2023 to 1/12/2024.
one hundred sixty-four children will be divided into 4 groups each group will have 41 patients. Groups 1-3 will be intervention groups, patients of which received a non-pharmacological intervention during mild regular painful maneuvers as cannula insertion, venipuncture, arterial puncture, heel prick, Group 1 will receive nonnutritive suckling. Group 2 will receive oral glucose 25% Group 3 will undergo facilitated tuckling Group 4 will be a control group (receive no nonpharmacological intervention). The pain response in each group will be assessed by CRIES score CRIES comes from (Crying, requires oxygen, Increased vital signs, Expression, Sleep). The scale may be taken over time to monitor the infant's (32 to 60 weeks' gestational age) recovery or response to interventions.
Minimum score is 0 whilst maximum score is 10. The higher the score, the greater the expression of pain. If the CRIES score is greater than 4, further pain assessment should be undertaken, and analgesic administration is indicated for a score of 6 or higher.
Read the detailed description
Pain is defined as unpleasant sensory and emotional experience associated with tissue damage. Newborns are especially vulnerable to pain and its deleterious effects, as they have larger receptive fields for nociceptive impulses and possibly a higher density of nerve endings and concentration of substance P receptors 1) . The density of proprioceptive nerve ending is equal to the adult, also they have a lower threshold for excitation and sensitization.
In neonates the harmful effects of pain include irritability, fear, sense of mistrust towards caregiver, disturbed sleep and wakefulness cycle, delayed wound healing, altered immunological functions, biochemical alterations in energy metabolism2), negative effects on the developing brain and behavior. Neonates requiring intensive care admission exposed to various types of painful stimuli such as venipuncture, arterial puncture, suction, catheterization or invasive procedures as, lumbar puncture, CVC and bronchoscopy.
The responses to pain in a newborn are nonverbal and include physiological and autonomic manifestations as changes in heart rate, respiratory rate, blood pressure and oxygen saturation3), also behavioral changes as crying, change in facial expressions and body movement. These parameters are used for pain assessment in various scales4). For example, total facial activity and cluster of specific facial findings (brow bulge, eye squeeze, nasolabial furrow, open mouth) were associated with acute and postoperative pain5*6).
Example of most commonly used scales in assessment of pain7), the Premature Infant Pain Profile (PIPP)8), Neonatal Pain Agitation and Sedation Scale (N-PASS)9), Neonatal Infant Pain Scale (NIPS) and the CRIES scale (Crying, Requires Oxygen Saturation, Increased Vital Signs, Expression, Sleeplessness).12)
- Conditions
- Pain Management, Neonates Pain Management
- Being tested
- no intervention, nonnutritive suckling, oral glucose 25%, facilitated tuckling
- Keywords
- pain management in neonates, nonpharmacological neonatal pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionBehavioural
Group 4 will receive no intervention
nonnutritive sucklingDrug
Group 1 will receive nonnutritive suckling
oral glucose 25%Drug
Group 2 will receive oral glucose 25%
facilitated tucklingBehavioural
Group 3 will undergo facilitated tuckling
| Study group | Role | What they receive |
|---|---|---|
| Group 4 (placebo) | Placebo comparator | this group will be A control group receive no intervention. Receives: Behavioral: no intervention |
| group 1 (interventional group) | Experimental | Intervention groups which will receive nonnutritive suckling. Receives: Drug: nonnutritive suckling |
| group 2 (interventional group ) | Experimental | Group 2 will receive oral glucose 25% Receives: Drug: oral glucose 25% |
| Group 3 (interventional group) | Experimental | Group 3 will undergo facilitated tuckling Receives: Behavioral: facilitated tuckling |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRIES SCORE
164 children will be divided into 4 groups each group will have 41 patients. Groups 1-3 will be intervention groups, patients of which received a non-pharmacological intervention during mild regular painful maneuvers as cannula insertion. Group 1,2,3 will be receiving nonpharmacological interventions Group 4 will be a control group. The pain response in each group will be assessed by CRIES score CRIES comes from (Crying, Requires oxygen, Increased vital signs, Expression, Sleep). The scale may be taken over time to monitor the infant's (32 to 60 weeks' gestational age) recovery or response to interventions. Minimum score is 0 whilst maximum score is 10. The higher the score, the greater the expression of pain. If the CRIES score is greater than 4, further pain assessment should be undertaken.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Mustafaa Abu Zaid, Assiut University
- Investigators
- Safaa Mustafaa Abo Zaid, pediatric resident, Principal investigator, Assiut UniversityZeinab Mohie Eldeen, professor, Study director, Assiut UniversityAmira Mohamed shalaby, Assistant Professor, Study director, Assiut UniversityRanda AbdAlbadea Abdelaleem, Lecturer of Pediatrics, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155825
- Sponsor's protocol ID
- pain management in neonate
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krechel SW, Bildner J. CRIES: a new neonatal postoperative pain measurement score. Initial testing of validity and reliability. Paediatr Anaesth. 1995;5(1):53-61. doi: 10.1111/j.1460-9592.1995.tb00242.x.
PubMed 8521311Castagno E, Fabiano G, Carmellino V, Cerchio R, De Vito B, Lauria B, Mercurio G, Coscia A, Ponte G, Bondone C. Neonatal pain assessment scales: review of the literature. Prof Inferm. 2022 Apr 1;75(1):17-28. doi: 10.7429/pi.2022.751017. English, Italian.
PubMed 36962062Bucsea O, Pillai Riddell R. Non-pharmacological pain management in the neonatal intensive care unit: Managing neonatal pain without drugs. Semin Fetal Neonatal Med. 2019 Aug;24(4):101017. doi: 10.1016/j.siny.2019.05.009. Epub 2019 Jun 5.
PubMed 31326301Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak A, Patel D, Nimbalkar S. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2018 Apr 15;55(4):292-296. Epub 2018 Feb 9.
PubMed 29428919Maxwell LG, Fraga MV, Malavolta CP. Assessment of Pain in the Newborn: An Update. Clin Perinatol. 2019 Dec;46(4):693-707. doi: 10.1016/j.clp.2019.08.005. Epub 2019 Aug 19.
PubMed 31653303
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonpharmacological Pain Management in Neonate (A Randomized Controlled Study)
- ClinicalTrials.gov ID
- NCT06155825
- Acronym / sponsor ID
- pain management in neonate
- Conditions
- Pain Management, Neonates Pain Management
- Keywords
- pain management in neonates, nonpharmacological neonatal pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 4 Dec 2023 (actual)
- 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.
This is A randomized controlled study which aim to:
The primary aim in this study is assessment of non-pharmacological pain management in neonate and determine the most effective.
The secondary aim of this study is to introduce idea of neonatal pain management. and record its effect on hospital stay and Duration to reach full enteral feeding. This prospective study will be conducted at NICU unit of Assiut University pediatrician hospital, Duration of study 1 year from 1/12/2023 to 1/12/2024.
one hundred sixty-four children will be divided into 4 groups each group will have 41 patients. Groups 1-3 will be intervention groups, patients of which received a non-pharmacological intervention during mild regular painful maneuvers as cannula insertion, venipuncture, arterial puncture, heel prick, Group 1 will receive nonnutritive suckling. Group 2 will receive oral glucose 25% Group 3 will undergo facilitated tuckling Group 4 will be a control group (receive no nonpharmacological intervention). The pain response in each group will be assessed by CRIES score CRIES comes from (Crying, requires oxygen, Increased vital signs, Expression, Sleep). The scale may be taken over time to monitor the infant's (32 to 60 weeks' gestational age) recovery or response to interventions.
Minimum score is 0 whilst maximum score is 10. The higher the score, the greater the expression of pain. If the CRIES score is greater than 4, further pain assessment should be undertaken, and analgesic administration is indicated for a score of 6 or higher.
Detailed description
Pain is defined as unpleasant sensory and emotional experience associated with tissue damage. Newborns are especially vulnerable to pain and its deleterious effects, as they have larger receptive fields for nociceptive impulses and possibly a higher density of nerve endings and concentration of substance P receptors 1) . The density of proprioceptive nerve ending is equal to the adult, also they have a lower threshold for excitation and sensitization.
In neonates the harmful effects of pain include irritability, fear, sense of mistrust towards caregiver, disturbed sleep and wakefulness cycle, delayed wound healing, altered immunological functions, biochemical alterations in energy metabolism2), negative effects on the developing brain and behavior. Neonates requiring intensive care admission exposed to various types of painful stimuli such as venipuncture, arterial puncture, suction, catheterization or invasive procedures as, lumbar puncture, CVC and bronchoscopy.
The responses to pain in a newborn are nonverbal and include physiological and autonomic manifestations as changes in heart rate, respiratory rate, blood pressure and oxygen saturation3), also behavioral changes as crying, change in facial expressions and body movement. These parameters are used for pain assessment in various scales4). For example, total facial activity and cluster of specific facial findings (brow bulge, eye squeeze, nasolabial furrow, open mouth) were associated with acute and postoperative pain5*6).
Example of most commonly used scales in assessment of pain7), the Premature Infant Pain Profile (PIPP)8), Neonatal Pain Agitation and Sedation Scale (N-PASS)9), Neonatal Infant Pain Scale (NIPS) and the CRIES scale (Crying, Requires Oxygen Saturation, Increased Vital Signs, Expression, Sleeplessness).12)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 4 (placebo) | Placebo comparator | Behavioral: no interventionthis group will be A control group receive no intervention. |
| group 1 (interventional group) | Experimental | Drug: nonnutritive sucklingIntervention groups which will receive nonnutritive suckling. |
| group 2 (interventional group ) | Experimental | Drug: oral glucose 25%Group 2 will receive oral glucose 25% |
| Group 3 (interventional group) | Experimental | Behavioral: facilitated tucklingGroup 3 will undergo facilitated tuckling |
Who may qualify
- Ages
- 32 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy term newborn 32 week or more.
- Newborn during routine painful maneuvers as venipuncture and arterial puncture
Key exclusion criteria (1 listed)
- 1) Preterm < 32 week 2) Newborn with neurological impairment 3) Sedated newborn 4) Newborn with metabolic diseases 5) Newborn with congenital anomalies 6) Newborn undergoing operative intervention
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 |
|---|---|---|
| no interventionGroup 4 will receive no intervention | Behavioural | Group 4 (placebo) |
| nonnutritive sucklingGroup 1 will receive nonnutritive suckling | Drug | group 1 (interventional group) |
| oral glucose 25%Group 2 will receive oral glucose 25% | Drug | group 2 (interventional group ) |
| facilitated tucklingGroup 3 will undergo facilitated tuckling | Behavioural | Group 3 (interventional group) |
Primary outcome
CRIES SCORE
Time frame: one year
164 children will be divided into 4 groups each group will have 41 patients. Groups 1-3 will be intervention groups, patients of which received a non-pharmacological intervention during mild regular painful maneuvers as cannula insertion. Group 1,2,3 will be receiving nonpharmacological interventions Group 4 will be a control group. The pain response in each group will be assessed by CRIES score CRIES comes from (Crying, Requires oxygen, Increased vital signs, Expression, Sleep). The scale may be taken over time to monitor the infant's (32 to 60 weeks' gestational age) recovery or response to interventions. Minimum score is 0 whilst maximum score is 10. The higher the score, the greater the expression of pain. If the CRIES score is greater than 4, further pain assessment should be undertaken.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Background: PubMed 8521311Krechel SW, Bildner J. CRIES: a new neonatal postoperative pain measurement score. Initial testing of validity and reliability. Paediatr Anaesth. 1995;5(1):53-61. doi: 10.1111/j.1460-9592.1995.tb00242.x.
- Background: PubMed 36962062Castagno E, Fabiano G, Carmellino V, Cerchio R, De Vito B, Lauria B, Mercurio G, Coscia A, Ponte G, Bondone C. Neonatal pain assessment scales: review of the literature. Prof Inferm. 2022 Apr 1;75(1):17-28. doi: 10.7429/pi.2022.751017. English, Italian.
- Background: PubMed 31326301Bucsea O, Pillai Riddell R. Non-pharmacological pain management in the neonatal intensive care unit: Managing neonatal pain without drugs. Semin Fetal Neonatal Med. 2019 Aug;24(4):101017. doi: 10.1016/j.siny.2019.05.009. Epub 2019 Jun 5.
- Background: PubMed 29428919Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak A, Patel D, Nimbalkar S. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2018 Apr 15;55(4):292-296. Epub 2018 Feb 9.
- Background: PubMed 31653303Maxwell LG, Fraga MV, Malavolta CP. Assessment of Pain in the Newborn: An Update. Clin Perinatol. 2019 Dec;46(4):693-707. doi: 10.1016/j.clp.2019.08.005. Epub 2019 Aug 19.
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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.
Safaa Mustafaa Abu Zaid, Resident of Pediatrics contact
Safaa Mustafaa Abo Zaid, pediatric resident principal investigator
Assiut University
Zeinab Mohie Eldeen, professor study director
Assiut University
Amira Mohamed shalaby, Assistant Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing nonnutritive suckling, oral glucose 25% and facilitated tuckling in people with Pain Management and Neonates Pain Management, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safaa Mustafaa Abu Zaid, Resident of Pediatrics (01098067714 ext. 01116318762, safaamustafaa5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRIES SCORE (time frame: one year). 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 NCT06155825, which also lists 5 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 4 Dec 2023.