PainPhase 3NCT01190995
Role of Repeated Painful Procedures in Preterm Neonates on Short Term Neurobehavioural Outcome
A Phase 3 study testing 24% Sucrose in people with Pain, run by Lady Hardinge Medical College at 2 sites in India.
Trial summary
Procedural pain in neonates is recently acknowledged entity and many studies on the use of pharmacological as well as non pharmacological interventions for alleviation of this pain have been done. Of these, sucrose with or without non nutritive sucking has been the most widely studied and accepted form of pain relief. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Pain
- What is being tested?
- 24% Sucrose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 2 sitesIndia
- Study dates
- Jul 2010to Nov 2011
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All preterms (more than equal to 32 weeks to less than 37 weeks)
- within first 48 hrs of post natal life
- Clinically stable from respiratory and hemodynamic point of view
- Parental consent
Who cannot join
- neonates requiring ventilatory support
- neonates with any neurological impairment(HIE ,seizures)
- receiving opiates or born to mothers receiving opiates
- newborns who have received muscle relaxants ,sedatives or analgesics
- grade 3 or 4 IVH
- major congenital anomalies
Show all 9Show fewer
- 5 mins apgar of less than 7
- Neonates undergoing any surgery
- Birth trauma
Trial locations and contacts
2 sites in 1 country.
India2 sites
Lady Hardinge Medical College,New Delhi
Delhi
Lady Hardinge Medical College
New Delhi, New Delhi, 110001
About this study
Official title: A Randomised Controlled Trial to Evaluate the Role of Repeated Painful Procedures in Preterm Neonates on Short Term Neurobehavioural Outcome
Procedural pain in neonates is recently acknowledged entity and many studies on the use of pharmacological as well as non pharmacological interventions for alleviation of this pain have been done. Of these, sucrose with or without non nutritive sucking has been the most widely studied and accepted form of pain relief. Its analgesic effect is thought to be mediated by endogenous opioid pathways activated by sweet taste (orogustatory effect).
Although, guidelines based on systematic reviews and meta-analysis for pain management recommend the use of sucrose solutions for pain relief during procedures, the use of repeated doses of sucrose with preterm neonates requires further investigation.
Pain may have profound consequences for preterm neonates during a critical time of brain development. Data derived from animal models suggests that repeated painful stimuli may result in structural and functional reorganization of the nervous system and alteration in future pain response. Early pain experience during this critical period in development are thought to have immediate and long term consequences that could influence physiological, behavioral and developmental outcomes. Early repetitive procedural pain related stress in very preterm neonates is associated with poorer neurobehaviour in first 2 years of life.1 This study aims to assess the effect of repeated painful stimuli on short term neurobehaviour of preterm infants and the efficacy of repeated doses of sucrose used for pain relief.
Read the detailed description
DEFINITION OF PAIN - an unpleasant sensory and emotional experience with actual or potential damage or described in terms of such damage (note that the inability to communicate verbally or non verbally does not negate the possibility that an individual is having pain and is in need of appropriate pain relieving treatment)
HISTORICAL BACKGROUND- we as clinicians have emerged from a period of relative neglect of neonatal pain and are now recognizing the immediate and long term impact of pain on the neonatal development as well as the need to alleviate pain effectively. Neonatal pain has been acknowledged and Paediatric societies such as American Academy of Paediatrics and Canadian paediatric society (2000) have adopted specific guidelines on pain relief in neonates .
LONG TERM EFFECTS OF CHRONIC PAIN -Early repeated procedural pain in NICU has been proposed as one of the factors that may contribute to altered development of cognition ,motor function and behaviour in infants and children born preterm.The vulnerability of preterms is well established due to their lower pain threshold ,sensitization from repeated pain and immature systems for maintaining homeostasis .For infants with extremely immature physiological and neurobehavioural systems ,continual adaptation to repeated challenges induces long term alterations in pain sensitivity, might affect generalized stress arousal systems and potentially affect the developing cytotexture of the brain. The physiologic perturbations associated with early prolonged exposure to episodic pain appear to contribute to altering the rapidly developing stress systems .Exposure to painful procedures in early neonatal period affects the long term neurobehavioural outcome.
.
SCALE USED TO ASSESS SHORT TERM NEUROBEHAVIOUR
NAPI (NEUROBEHAVIOURAL ASSESSMENT OF PRETERM INFANT) -The NAPI is appropriate for infants between 32 weeks post conceptional age and term. It assesses the relative maturity of functioning of preterm infants,with higher scores reflecting higher maturity , and can differentiate 2 weeks PCA . The clinical validity and sensitivity of NAPI were established using an index of medical complications based on a 1-5 classification range of degrees of complications21 The items in the motor development cluster include ventral suspension, prone head raising ,the crawling reflex ,forearm recoil ,power of active movements , and vigor of spontaneous movements .The alertness and orientation items include percent of time in an alert state ,duration and quality of alertness , quantitative response to inanimate and animate visual and auditory stimulation and qualitative ratings that express the nature of response.
LACUNAE IN KNOWLEDGE -Preterm infants are more prone to undergo multiple painful procedures due to their prolonged stay in the neonatal intensive care unit and their typical vulnerable clinical profile.It has now been proved that painful procedures lead to long term changes in the pain reactivity and also affect the long term neurobehavioural outcome in these preterm infants.When a medline search was carried out on the subject it did not return any result.Currently there is no study which has tried to explore the short term neurobehavioural outcome in preterm babies >32 weeks - <37 weeks of gestation who undergo multiple painful procedures during their NICU stay.The present study was thus planned to evaluate the role of sucrose analgesia in alleviating the pain caused by the routine NICU procedures over a period of 7 days and to assess the early neurobehavioural outcome in these babies with the help of a well designed double blinded randomized controlled trial.
- Conditions
- Pain
- Being tested
- 24% Sucrose, Placebo
- Keywords
- Pain, Neonate, Procedure, Neurobehavioural outcome
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24% SucroseDrug
Also called Sucrose
The enrolled neonates will be administered either a sterile solution of 24 % sucrose or double distilled water orally for a period of 7 days from enrollment. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure
PlaceboDrug
Also called Distilled Water
The patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | The enrolled neonates will be administered a sterile solution of 24 % sucrose orally for a period of 7 days from enrollment The patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure. Receives: Drug: 24% Sucrose; Drug: Placebo |
| Placebo | Placebo comparator | The enrolled neonates will be administered double distilled water orally for a period of 7 days from enrollment. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term neurobehaviour status at enrollment in the study and at 40weeks post conceptional age using the NAPI scale.
Short term neurobehaviour status at enrollment in the study and at 40weeks post conceptional age using the(Neurobehavioural Assessment of Preterm Infant) NAPI scale.
Measured: 40 weeks of post conceptional age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DR. VIKRAM DATTA, Lady Hardinge Medical College
- Investigators
- VIKRAM DATTA, MD, Study chair, Lady Hardinge Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190995
- Sponsor's protocol ID
- Pain and Neurobehaviour
- Status last verified
- Nov 2011
- First submitted
- 27 Aug 2010
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Evaluate the Role of Repeated Painful Procedures in Preterm Neonates on Short Term Neurobehavioural Outcome
- ClinicalTrials.gov ID
- NCT01190995
- Acronym / sponsor ID
- Pain and Neurobehaviour
- Conditions
- Pain
- Keywords
- Pain, Neonate, Procedure, Neurobehavioural outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Jul 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Aug 2010 (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.
Procedural pain in neonates is recently acknowledged entity and many studies on the use of pharmacological as well as non pharmacological interventions for alleviation of this pain have been done. Of these, sucrose with or without non nutritive sucking has been the most widely studied and accepted form of pain relief. Its analgesic effect is thought to be mediated by endogenous opioid pathways activated by sweet taste (orogustatory effect).
Although, guidelines based on systematic reviews and meta-analysis for pain management recommend the use of sucrose solutions for pain relief during procedures, the use of repeated doses of sucrose with preterm neonates requires further investigation.
Pain may have profound consequences for preterm neonates during a critical time of brain development. Data derived from animal models suggests that repeated painful stimuli may result in structural and functional reorganization of the nervous system and alteration in future pain response. Early pain experience during this critical period in development are thought to have immediate and long term consequences that could influence physiological, behavioral and developmental outcomes. Early repetitive procedural pain related stress in very preterm neonates is associated with poorer neurobehaviour in first 2 years of life.1 This study aims to assess the effect of repeated painful stimuli on short term neurobehaviour of preterm infants and the efficacy of repeated doses of sucrose used for pain relief.
Detailed description
DEFINITION OF PAIN - an unpleasant sensory and emotional experience with actual or potential damage or described in terms of such damage (note that the inability to communicate verbally or non verbally does not negate the possibility that an individual is having pain and is in need of appropriate pain relieving treatment)
HISTORICAL BACKGROUND- we as clinicians have emerged from a period of relative neglect of neonatal pain and are now recognizing the immediate and long term impact of pain on the neonatal development as well as the need to alleviate pain effectively. Neonatal pain has been acknowledged and Paediatric societies such as American Academy of Paediatrics and Canadian paediatric society (2000) have adopted specific guidelines on pain relief in neonates .
LONG TERM EFFECTS OF CHRONIC PAIN -Early repeated procedural pain in NICU has been proposed as one of the factors that may contribute to altered development of cognition ,motor function and behaviour in infants and children born preterm.The vulnerability of preterms is well established due to their lower pain threshold ,sensitization from repeated pain and immature systems for maintaining homeostasis .For infants with extremely immature physiological and neurobehavioural systems ,continual adaptation to repeated challenges induces long term alterations in pain sensitivity, might affect generalized stress arousal systems and potentially affect the developing cytotexture of the brain. The physiologic perturbations associated with early prolonged exposure to episodic pain appear to contribute to altering the rapidly developing stress systems .Exposure to painful procedures in early neonatal period affects the long term neurobehavioural outcome.
.
SCALE USED TO ASSESS SHORT TERM NEUROBEHAVIOUR
NAPI (NEUROBEHAVIOURAL ASSESSMENT OF PRETERM INFANT) -The NAPI is appropriate for infants between 32 weeks post conceptional age and term. It assesses the relative maturity of functioning of preterm infants,with higher scores reflecting higher maturity , and can differentiate 2 weeks PCA . The clinical validity and sensitivity of NAPI were established using an index of medical complications based on a 1-5 classification range of degrees of complications21 The items in the motor development cluster include ventral suspension, prone head raising ,the crawling reflex ,forearm recoil ,power of active movements , and vigor of spontaneous movements .The alertness and orientation items include percent of time in an alert state ,duration and quality of alertness , quantitative response to inanimate and animate visual and auditory stimulation and qualitative ratings that express the nature of response.
LACUNAE IN KNOWLEDGE -Preterm infants are more prone to undergo multiple painful procedures due to their prolonged stay in the neonatal intensive care unit and their typical vulnerable clinical profile.It has now been proved that painful procedures lead to long term changes in the pain reactivity and also affect the long term neurobehavioural outcome in these preterm infants.When a medline search was carried out on the subject it did not return any result.Currently there is no study which has tried to explore the short term neurobehavioural outcome in preterm babies >32 weeks - <37 weeks of gestation who undergo multiple painful procedures during their NICU stay.The present study was thus planned to evaluate the role of sucrose analgesia in alleviating the pain caused by the routine NICU procedures over a period of 7 days and to assess the early neurobehavioural outcome in these babies with the help of a well designed double blinded randomized controlled trial.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Drug: 24% Sucrose, Drug: PlaceboThe enrolled neonates will be administered a sterile solution of 24 % sucrose orally for a period of 7 days from enrollment The patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure. |
| Placebo | Placebo comparator | Drug: PlaceboThe enrolled neonates will be administered double distilled water orally for a period of 7 days from enrollment. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All preterms (more than equal to 32 weeks to less than 37 weeks)
- within first 48 hrs of post natal life
- Clinically stable from respiratory and hemodynamic point of view
- Parental consent
Key exclusion criteria (9 listed)
- neonates requiring ventilatory support
- neonates with any neurological impairment(HIE ,seizures)
- receiving opiates or born to mothers receiving opiates
- newborns who have received muscle relaxants ,sedatives or analgesics
- grade 3 or 4 IVH
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 |
|---|---|---|
| 24% SucroseAlso: SucroseThe enrolled neonates will be administered either a sterile solution of 24 % sucrose or double distilled water orally for a period of 7 days from enrollment. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure | Drug | Sucrose |
| PlaceboAlso: Distilled WaterThe patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure | Drug | Placebo, Sucrose |
Primary outcome
Short term neurobehaviour status at enrollment in the study and at 40weeks post conceptional age using the NAPI scale.
Time frame: 40 weeks of post conceptional age.
Short term neurobehaviour status at enrollment in the study and at 40weeks post conceptional age using the(Neurobehavioural Assessment of Preterm Infant) NAPI scale.
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 24 Nov 2011.
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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.
VIKRAM DATTA, MD study chair
Lady Hardinge Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 24% Sucrose in people with Pain, run by Lady Hardinge Medical College at 2 sites in India.
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 9 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 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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. 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.
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?
Short term neurobehaviour status at enrollment in the study and at 40weeks post conceptional age using the NAPI scale. (time frame: 40 weeks of post conceptional age.). 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 24 Nov 2011.