Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial
Background: Eye exam for Retinopathy of prematurity (ROP) is a painful procedure and pharmacological analgesia might be ineffective. We hypothesized that magnetic auricular acupuncture (MAA) compared to placebo will decrease pain during ROP exam in preterm infants.Methods: Multicentre randomized con...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2020-12-01
|
| Series: | Frontiers in Pediatrics |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2020.615008/full |
| _version_ | 1819072935474757632 |
|---|---|
| author | Kimberly M. L. Gan Kimberly M. L. Gan Ju-Lee Oei Ju-Lee Oei Im Quah-Smith Im Quah-Smith Azanna A. Kamar Alexis A. D. Lordudass Kian D. Liem Kwee Bee Lindrea Mary Daly Nilima Gaunker Avneet K. Mangat Avneet K. Mangat Maryna Yaskina Georg M. Schmölzer Georg M. Schmölzer |
| author_facet | Kimberly M. L. Gan Kimberly M. L. Gan Ju-Lee Oei Ju-Lee Oei Im Quah-Smith Im Quah-Smith Azanna A. Kamar Alexis A. D. Lordudass Kian D. Liem Kwee Bee Lindrea Mary Daly Nilima Gaunker Avneet K. Mangat Avneet K. Mangat Maryna Yaskina Georg M. Schmölzer Georg M. Schmölzer |
| author_sort | Kimberly M. L. Gan |
| collection | DOAJ |
| description | Background: Eye exam for Retinopathy of prematurity (ROP) is a painful procedure and pharmacological analgesia might be ineffective. We hypothesized that magnetic auricular acupuncture (MAA) compared to placebo will decrease pain during ROP exam in preterm infants.Methods: Multicentre randomized controlled trial conducted in three hospitals (Australia, Canada, and Malaysia). Eligibility: >32 weeks, ROP exam, not sedated, and parental consent. A total of 100 infants were randomized (1:1) to MAA (n = 50) or placebo (n = 50). MAA stickers or placebo were placed on both ears by an unblinded investigator. Pain was assessed using the Premature Infant Pain Profile. Primary analyses were by intention-to-treat. ClinicalTrials.gov:NCT03650621.Findings: The mean (standard deviation, SD) gestation, birthweight, and postnatal age were (MAA 28(3) vs. placebo 28(2) weeks; MAA 1,057(455) vs. placebo 952(273) g; MAA 7(3) vs. placebo 7(3) weeks. Placebo infants had significantly higher PIPP scores during [mean difference 1.6 points (95%CI 0.1–3.1)] and 1 h mean difference 1.5 points (95%CI 0.7–2.2) after the procedure (p < 0.03). Heart rate was lower (173(22) vs. 184(18)/min) and oxygen saturations were higher (93.8(6.2) vs. 91.7(6.1)%, p = 0.05) in MAA infants. No adverse effects.Interpretation: MAA may reduce physiological pain responses during and after ROP exam in preterm infants. Assessment of long-term effects are warranted.Clinical trial registration: www.ClinicalTrials.gov, identifier: NCT03650621. |
| first_indexed | 2024-12-21T17:45:38Z |
| format | Article |
| id | doaj.art-39030b5f9557499a80d5877d2b9d677e |
| institution | Directory Open Access Journal |
| issn | 2296-2360 |
| language | English |
| last_indexed | 2024-12-21T17:45:38Z |
| publishDate | 2020-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pediatrics |
| spelling | doaj.art-39030b5f9557499a80d5877d2b9d677e2022-12-21T18:55:31ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602020-12-01810.3389/fped.2020.615008615008Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled TrialKimberly M. L. Gan0Kimberly M. L. Gan1Ju-Lee Oei2Ju-Lee Oei3Im Quah-Smith4Im Quah-Smith5Azanna A. Kamar6Alexis A. D. Lordudass7Kian D. Liem8Kwee Bee Lindrea9Mary Daly10Nilima Gaunker11Avneet K. Mangat12Avneet K. Mangat13Maryna Yaskina14Georg M. Schmölzer15Georg M. Schmölzer16Faculty of Medicine, University of New South Wales, Kensington, NSW, AustraliaSchool of Women's and Children's Health, University of New South Wales, Kensington, NSW, AustraliaSchool of Women's and Children's Health, University of New South Wales, Kensington, NSW, AustraliaDepartment of Newborn Care, The Royal Hospital for Women, Randwick, NSW, AustraliaSchool of Women's and Children's Health, University of New South Wales, Kensington, NSW, AustraliaRoseville Wellness Group, Roseville, NSW, AustraliaNeonatology Unit, University of Malaya Medical Centre, Kuala Lumpur, MalaysiaNeonatology Unit, University of Malaya Medical Centre, Kuala Lumpur, MalaysiaDepartment of Neonatology, Radboudumc Amalia Children's Hospital, Nijmegen, NetherlandsDepartment of Newborn Care, The Royal Hospital for Women, Randwick, NSW, AustraliaDepartment of Newborn Care, The Royal Hospital for Women, Randwick, NSW, AustraliaDepartment of Newborn Care, The Royal Hospital for Women, Randwick, NSW, AustraliaNeonatal Research Unit, Centre for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, Edmonton, AB, CanadaDepartment of Paediatrics, University of Alberta, Edmonton, AB, CanadaWomen and Children's Health Research Institute (WCHRI), University of Alberta, Edmonton, AB, CanadaNeonatal Research Unit, Centre for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, Edmonton, AB, CanadaDepartment of Paediatrics, University of Alberta, Edmonton, AB, CanadaBackground: Eye exam for Retinopathy of prematurity (ROP) is a painful procedure and pharmacological analgesia might be ineffective. We hypothesized that magnetic auricular acupuncture (MAA) compared to placebo will decrease pain during ROP exam in preterm infants.Methods: Multicentre randomized controlled trial conducted in three hospitals (Australia, Canada, and Malaysia). Eligibility: >32 weeks, ROP exam, not sedated, and parental consent. A total of 100 infants were randomized (1:1) to MAA (n = 50) or placebo (n = 50). MAA stickers or placebo were placed on both ears by an unblinded investigator. Pain was assessed using the Premature Infant Pain Profile. Primary analyses were by intention-to-treat. ClinicalTrials.gov:NCT03650621.Findings: The mean (standard deviation, SD) gestation, birthweight, and postnatal age were (MAA 28(3) vs. placebo 28(2) weeks; MAA 1,057(455) vs. placebo 952(273) g; MAA 7(3) vs. placebo 7(3) weeks. Placebo infants had significantly higher PIPP scores during [mean difference 1.6 points (95%CI 0.1–3.1)] and 1 h mean difference 1.5 points (95%CI 0.7–2.2) after the procedure (p < 0.03). Heart rate was lower (173(22) vs. 184(18)/min) and oxygen saturations were higher (93.8(6.2) vs. 91.7(6.1)%, p = 0.05) in MAA infants. No adverse effects.Interpretation: MAA may reduce physiological pain responses during and after ROP exam in preterm infants. Assessment of long-term effects are warranted.Clinical trial registration: www.ClinicalTrials.gov, identifier: NCT03650621.https://www.frontiersin.org/articles/10.3389/fped.2020.615008/fullnewbornretinopathy of prematuritypainacupunctureacupunctural analgesia |
| spellingShingle | Kimberly M. L. Gan Kimberly M. L. Gan Ju-Lee Oei Ju-Lee Oei Im Quah-Smith Im Quah-Smith Azanna A. Kamar Alexis A. D. Lordudass Kian D. Liem Kwee Bee Lindrea Mary Daly Nilima Gaunker Avneet K. Mangat Avneet K. Mangat Maryna Yaskina Georg M. Schmölzer Georg M. Schmölzer Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial Frontiers in Pediatrics newborn retinopathy of prematurity pain acupuncture acupunctural analgesia |
| title | Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial |
| title_full | Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial |
| title_fullStr | Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial |
| title_full_unstemmed | Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial |
| title_short | Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial |
| title_sort | magnetic non invasive auricular acupuncture during eye exam for retinopathy of prematurity in preterm infants a multicentre randomized controlled trial |
| topic | newborn retinopathy of prematurity pain acupuncture acupunctural analgesia |
| url | https://www.frontiersin.org/articles/10.3389/fped.2020.615008/full |
| work_keys_str_mv | AT kimberlymlgan magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT kimberlymlgan magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT juleeoei magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT juleeoei magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT imquahsmith magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT imquahsmith magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT azannaakamar magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT alexisadlordudass magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT kiandliem magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT kweebeelindrea magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT marydaly magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT nilimagaunker magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT avneetkmangat magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT avneetkmangat magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT marynayaskina magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT georgmschmolzer magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial AT georgmschmolzer magneticnoninvasiveauricularacupunctureduringeyeexamforretinopathyofprematurityinpreterminfantsamulticentrerandomizedcontrolledtrial |