Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767178
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2021-02-14
Brief Title:
Pain Management During Screening for Retinopathy of Prematurity
Sponsor:
Istanbul Medeniyet University
Organization:
Istanbul Medeniyet University
Study Overview
Official Title:
Oral Ibuprofen Versus Oral Paracetamol in Pain Management During Screening for Retinopathy of Prematurity A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Abstract Background Screening examinations for retinopathy of prematurity ROP is critical to reduce ROP-related vision loss however the procedure is painful and uncomfortable and topical anesthetics do not completely suppress the painful responses The number of safe and effective pharmacological options to reduce pain during eye examinations for ROP screening in preterm infants is limited
Objective This study compared the efficacy of oral ibuprofen and oral paracetamol in reducing pain during screening for ROP in preterm infants
Design This prospective observational study was conducted at a tertiary-care neonatal intensive care units Forty-four preterm infants with gestational age 32 weeks undergoing ROP screening were included Each enrolled infant received either oral ibuprofen 10 mgkg n 22 or oral paracetamol 10 mgkg n 22 one hour before eye examination The primary outcome measure was pain assessed by the Neonatal Pain Agitation and Sedation N-PASS scale Secondary outcome measures were tachycardia bradycardia desaturations and crying time
Objective This study compared the efficacy of oral ibuprofen and oral paracetamol in reducing pain during screening for ROP in preterm infants
Design This prospective observational study was conducted at a tertiary-care neonatal intensive care units Forty-four preterm infants with gestational age 32 weeks undergoing ROP screening were included Each enrolled infant received either oral ibuprofen 10 mgkg n 22 or oral paracetamol 10 mgkg n 22 one hour before eye examination The primary outcome measure was pain assessed by the Neonatal Pain Agitation and Sedation N-PASS scale Secondary outcome measures were tachycardia bradycardia desaturations and crying time
Detailed Description:
Retinopathy of prematurity ROP is a physiopathological condition that develops upon abnormal proliferation of the retinal veins in neonates and its pathogenesis is unknown1 With the advancements in neonate care the survival rate of premature babies with extremely low gestational ages and birth weights has increased significantly however this has also resulted in an increasing incidence of ROP which may lead to vision defects andor blindness Early diagnosis and timely and effective treatment may prevent vision loss and thus improve the developmental process and the quality of life of these infants Therefore recurring screening with retinal examination is essential to identify neonates who need ROP treatment2 3 The American Academy of Pediatrics and American Academy of Ophthalmology recommend ROP screening for preterm infants with a birth weight of 1500 g or a gestational age of 30 weeks and selected infants with a birth weight between 1500 and 2000 g or a gestational age of 30 weeks who have received cardiopulmonary supportive therapy or who are considered by the attending clinician to be at risk for the development of ROP4 The ophthalmological examinations for screening ROP involve repeated use of mydriatic eye drops physical constriction forced opening of the eyelids insertion of the blepharostat scleral indentation and dense light all of which cause pain and stress to the infant5 6 The extreme and long-term unreduced pain resulting from the interventions applied in the neonatal intensive care units NICU may generally cause life-threatening effects in organs and systems Inadequate management of pain in preterm neonates can cause physiological changes and may also obscure the behavior of the infant interactions between the family and the infant and the adaptation of the infant to the social world causing neurological and behavioral disorders and negatively affecting growth7 8 9 10 Thus determination of optimal strategies for stress reduction and pain management related to these medical procedures is important in order to minimize the discomfort experienced by these neonates
In order to reduce the pain and stress related to ROP examination non-pharmacological methods including the use of pacifiers skin-to-skin touch swaddling kangaroo care positioning musical therapy breast milk and breast feeding single or recurring doses of oral sucrose and personalized developmental care applications have been used5 11 12 13 14 However a recent meta-analysis of randomized controlled studies evaluated a variety of non-pharmacological pain-reducing interventions in addition to topical ophthalmic anesthetics for ROP examination Although multisensory pain treatments eg oral dextrosesucrose solution breast milk swinging singing non-feeding suction swaddling may reduce the pain to varying degrees no specific treatment has been reported to show significant pain-relief ability The Premature Infant Pain Profile PIPP score in most of the studies was 1211 Pharmacological methods are used for pain relief as well as non-pharmacological in neonates The pharmacological agents include local anesthetics non-steroidal anti-inflammatory drugs NSAIDs and opioid medications15 Although topical anesthetics are routinely used in ROP examination in the NICU they do not offer complete relief from pain12 Moreover opioid analgesics should be used carefully due to their adverse effects such as respiratory depression apnea bradycardia hypotension intestinal hypoperistalsis and bladder dysfunction 16 NSAIDs are commonly used in newborns and children as antipyretic agents to control fever and as analgesic anti-inflammatory and vasoactive agents to manage pain and modulate inflammation17 Paracetamol shows analgesic and antipyretic effects by inhibiting the cyclooxygenase COX-2 enzyme17 It can be used safely in neonates during mild to moderately painful procedures and in the postoperative period Malnory et al showed that the preoperative use of paracetamol during circumcision of late preterm and term infants reduced pain within the first 24 h18 Ceelie et al reported that the intravenous use of paracetamol in neonates and infants after major surgeries reduced the need for morphine in the first 48 h following surgery19 Ibuprofen another NSAID inhibits COX-1 and COX-2 enzymes to show analgesic antipyretic and anti-inflammatory effects17 However the role of ibuprofen in reducing pain in neonates has not been studied in detail Recently these two medications are commonly used in NICUs for ductus closure20 To our knowledge no previous study has compared the pain-reducing effect of ibuprofen and paracetamol in preterm infants during ROP examinations Thus this study aimed to compare the pain-reducing effects of single-dose ibuprofen and paracetamol in preterm infants during ROP examination by using the Neonatal Pain Agitation and Sedation N-PASS scale
In order to reduce the pain and stress related to ROP examination non-pharmacological methods including the use of pacifiers skin-to-skin touch swaddling kangaroo care positioning musical therapy breast milk and breast feeding single or recurring doses of oral sucrose and personalized developmental care applications have been used5 11 12 13 14 However a recent meta-analysis of randomized controlled studies evaluated a variety of non-pharmacological pain-reducing interventions in addition to topical ophthalmic anesthetics for ROP examination Although multisensory pain treatments eg oral dextrosesucrose solution breast milk swinging singing non-feeding suction swaddling may reduce the pain to varying degrees no specific treatment has been reported to show significant pain-relief ability The Premature Infant Pain Profile PIPP score in most of the studies was 1211 Pharmacological methods are used for pain relief as well as non-pharmacological in neonates The pharmacological agents include local anesthetics non-steroidal anti-inflammatory drugs NSAIDs and opioid medications15 Although topical anesthetics are routinely used in ROP examination in the NICU they do not offer complete relief from pain12 Moreover opioid analgesics should be used carefully due to their adverse effects such as respiratory depression apnea bradycardia hypotension intestinal hypoperistalsis and bladder dysfunction 16 NSAIDs are commonly used in newborns and children as antipyretic agents to control fever and as analgesic anti-inflammatory and vasoactive agents to manage pain and modulate inflammation17 Paracetamol shows analgesic and antipyretic effects by inhibiting the cyclooxygenase COX-2 enzyme17 It can be used safely in neonates during mild to moderately painful procedures and in the postoperative period Malnory et al showed that the preoperative use of paracetamol during circumcision of late preterm and term infants reduced pain within the first 24 h18 Ceelie et al reported that the intravenous use of paracetamol in neonates and infants after major surgeries reduced the need for morphine in the first 48 h following surgery19 Ibuprofen another NSAID inhibits COX-1 and COX-2 enzymes to show analgesic antipyretic and anti-inflammatory effects17 However the role of ibuprofen in reducing pain in neonates has not been studied in detail Recently these two medications are commonly used in NICUs for ductus closure20 To our knowledge no previous study has compared the pain-reducing effect of ibuprofen and paracetamol in preterm infants during ROP examinations Thus this study aimed to compare the pain-reducing effects of single-dose ibuprofen and paracetamol in preterm infants during ROP examination by using the Neonatal Pain Agitation and Sedation N-PASS scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None