Use of Inhaled Colostrum to Control Pain in Neonatal Frenotomy and Comparison to Inhaled Lavender Essential Oil
NCT ID: NCT06869902
Last Updated: 2025-03-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
142 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-18
Study Completion Date
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Neonatal pain must be treated because it may have long-term negative effects. Frenotomy (clipping the tongue-tie) is a painful procedure where common strategies to relieve pain (give oral sucrose, let the baby suck, etc) cannot be used because the technique is performed on the tongue. Inhaling lavender essential oil (LEO) helps treat pain during painful procedures such as blood sampling, vaccination, and frenotomy. We aimed to determine whether smelling colostrum had similar effects as inhaled LEO during frenotomies. We conducted a prospective, randomized clinical trial between September 2023 and June 2024 and evaluated babies who underwent a frenotomy. We assessed pain using the NIPS score, heart rate, oxygen saturation, and crying time. After obtaining parental informed consent, we randomized patients into experimental and control groups. In both groups, we performed swaddling, administered oral sucrose, and let the newborn suck for 2 minutes. In the experimental group, we placed a gauze pad with two drops of colostrum, whereas in the control group, we used one drop of LEO 2 cm under the neonate's nose prior to and during the frenotomy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Analgesic Effect of Inhaled Lavender Essential Oil for Clipping of Tongue-ties
NCT04877392
Ankyloglossia
COMPLETED
NA
The Use of Lavender vs Vanilla Essential Oil as Complementary Analgesia for Frenotomy in Healthy Newborns
NCT04867824
Ankyloglossia
UNKNOWN
NA
Analgesia in Lingual Frenulotomy in the Newborn
NCT04440462
Frenulum Breve
COMPLETED
NA
Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn
NCT01274247
Neonatal Tongue-tie
Maternal Nipple Pain Upon Breastfeeding
Neonatal Latch Difficulties
TERMINATED
PHASE1/PHASE2
Post-Procedural Manual Manipulation for Infant Ankyloglossia
NCT06830148
Ankyloglossia
Breastfeeding Support
RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
We conducted a prospective, randomized clinical trial. Our hospital Ethics Committee (CEIm-PSMAR) approved this study (reference code: 2023/10996). Prior to patient enrollment we obtained a signed informed consent from the neonate's parents. This study was conducted according to the ethics code of the Barcelona Medical Association and the principles of the Helsinki-Fortaleza Declaration 2013, at the neonatal unit of a tertiary care hospital in Barcelona (Spain) within an area of influence of approximately 400,000 people, which experiences approximately 1,400 births per year. The target population for this study, and thus, inclusion criteria were healthy full-term neonates born at our center or less than 15 days old referred for a frenotomy, who had ankyloglossia according to the Hazelbaker tool between September 2023 and June 2024. We assess for the presence of ankyloglossia as part of the routine neonatal evaluation using the Hazelbaker tool to evaluate its impact on tongue movement and on breastfeeding. According to the Hazelbaker tool, ankyloglossia exists if appearance scores 8 points or less and/or function scores 11 points or less. We offer a frenotomy to all patients with ankyloglossia. During the study period, if we identified a patient with ankyloglossia, we offered the patient's parents the opportunity to participate in this study.
Patients were enrolled if their parents agreed to and signed a written informed consent. We only included patients who were breastfed, as after randomization we may need to get colostrum. Enrolled patients were randomized into case or control group by simple random sampling using sequentially numbered containers. During the frenotomy the neonate was taken to the neonatal unit and monitored with a pulse-oximeter (COVIDIEN Nellcor Portable SpO2 Patient Monitoring System PM10N, Covidien Ireland Limited, IDA Business \& Technology Park, Tullamore, Ireland) before, during and after the procedure. For both groups we swaddled, administered 1 mL of oral sucrose, and let the newborn suck for 2 minutes prior to the procedure. The control group had a 7 x 7 cm gauze pad with 1 drop (43.75 mg) of 100% pure LEO (Pranarôm España S.L.) placed 2 cm under their nose for 2 minutes prior to starting the frenotomy and for the duration of the procedure, whereas the experimental group had a gauze with 2 drops of colostrum of the patient's mother placed in the same way. We used two drops of colostrum but only one of LEO because the odor of colostrum is more subtle than that of LEO, and in our previous studies \[32-33\] we had used one drop of LEO, and that is how we routinely perform frenotomies. Once the procedure was completed, we removed the gauze pad and recorded vital signs, whether the baby cried or not, the seconds crying lasted, and the NIPS score on a data collection sheet. If a neonate cried, calming techniques such as holding, swaddling, and sucking were employed. A blinded observer assessed pain by means of the Neonatal Infant Pain Scale (NIPS) score (Figure 2) \[40\], crying duration, and whether there was a change in heart rate (HR) and/or in oxygen saturation (satO2) before and after the procedure.
In a previously published study where we compared performing frenotomies using complementary analgesia or not with inhaled LEO, we observed a mean (SD) crying time of 14.8 vs 24.6 (10.8 vs 27.6) seconds in favor of LEO \[32\]. In order to detect a difference of 10 seconds in crying time, we calculated that we needed a sample size of 71 patients per group in order to draw conclusions with a CI 95% and a power of 80%. We chose to evaluate pain by means of the increase of HR rather than via the NIPS score because in previous research, we obtained NIPS scores of 1.88-2.92 and 2.02-2.38, and a NIPS score less than 3 indicates no pain. We used the NIPS score to assess whether neonates exhibited pain when using inhaled colostrum instead of LEO.
We recorded demographic (sex, gestational age, birth weight, age in hours at the time of frenotomy) and clinical variables (HR and satO2 before, during, and after the procedure, whether the patient cried or not during the procedure, length of crying time in seconds, presence of side effects during the procedure (apnea, desaturation, others) and highest NIPS score within the first 5 minutes after the procedure). The attending staff were trained to assess the NIPS score before we started recruiting patients. Even though patients were swaddled, it was feasible to feel if they moved their legs or arms. The independent variable was the use of inhaled colostrum or inhaled LEO during frenotomy. The dependent variables were HR and satO2 pre and post procedure, presence of crying and duration, hours of life at the time of the frenotomy, and the NIPS score. The controlled variables were gestational age, sex, and birth weight.
Statistical analysis: Quantitative variables (gestational age, birth weight, age at frenotomy, heart rate pre and post-procedure, increase in heart rate post-procedure, oxygen saturation pre and post-procedure, decrease in oxygen saturation post-procedure, and duration of crying) are described using the mean, standard deviation and range; experimental vs control groups were compared with a Student's t-test. We assessed the equality of variances by using Levene's test and applied the result of the Student's t-test accordingly. Sex, the presence of crying, and adverse effects between the two groups are presented in percentages and compared using Fisher's exact test. Statistical significance was set for a p \<0.05. To perform statistical analyses we used STATA version 16.1 (StataCorp, College Station, TX, USA).
Patients were enrolled if their parents agreed to and signed a written informed consent. We only included patients who were breastfed, as after randomization we may need to get colostrum. Enrolled patients were randomized into case or control group by simple random sampling using sequentially numbered containers. During the frenotomy the neonate was taken to the neonatal unit and monitored with a pulse-oximeter (COVIDIEN Nellcor Portable SpO2 Patient Monitoring System PM10N, Covidien Ireland Limited, IDA Business \& Technology Park, Tullamore, Ireland) before, during and after the procedure. For both groups we swaddled, administered 1 mL of oral sucrose, and let the newborn suck for 2 minutes prior to the procedure. The control group had a 7 x 7 cm gauze pad with 1 drop (43.75 mg) of 100% pure LEO (Pranarôm España S.L.) placed 2 cm under their nose for 2 minutes prior to starting the frenotomy and for the duration of the procedure, whereas the experimental group had a gauze with 2 drops of colostrum of the patient's mother placed in the same way. We used two drops of colostrum but only one of LEO because the odor of colostrum is more subtle than that of LEO, and in our previous studies \[32-33\] we had used one drop of LEO, and that is how we routinely perform frenotomies. Once the procedure was completed, we removed the gauze pad and recorded vital signs, whether the baby cried or not, the seconds crying lasted, and the NIPS score on a data collection sheet. If a neonate cried, calming techniques such as holding, swaddling, and sucking were employed. A blinded observer assessed pain by means of the Neonatal Infant Pain Scale (NIPS) score (Figure 2) \[40\], crying duration, and whether there was a change in heart rate (HR) and/or in oxygen saturation (satO2) before and after the procedure.
In a previously published study where we compared performing frenotomies using complementary analgesia or not with inhaled LEO, we observed a mean (SD) crying time of 14.8 vs 24.6 (10.8 vs 27.6) seconds in favor of LEO \[32\]. In order to detect a difference of 10 seconds in crying time, we calculated that we needed a sample size of 71 patients per group in order to draw conclusions with a CI 95% and a power of 80%. We chose to evaluate pain by means of the increase of HR rather than via the NIPS score because in previous research, we obtained NIPS scores of 1.88-2.92 and 2.02-2.38, and a NIPS score less than 3 indicates no pain. We used the NIPS score to assess whether neonates exhibited pain when using inhaled colostrum instead of LEO.
We recorded demographic (sex, gestational age, birth weight, age in hours at the time of frenotomy) and clinical variables (HR and satO2 before, during, and after the procedure, whether the patient cried or not during the procedure, length of crying time in seconds, presence of side effects during the procedure (apnea, desaturation, others) and highest NIPS score within the first 5 minutes after the procedure). The attending staff were trained to assess the NIPS score before we started recruiting patients. Even though patients were swaddled, it was feasible to feel if they moved their legs or arms. The independent variable was the use of inhaled colostrum or inhaled LEO during frenotomy. The dependent variables were HR and satO2 pre and post procedure, presence of crying and duration, hours of life at the time of the frenotomy, and the NIPS score. The controlled variables were gestational age, sex, and birth weight.
Statistical analysis: Quantitative variables (gestational age, birth weight, age at frenotomy, heart rate pre and post-procedure, increase in heart rate post-procedure, oxygen saturation pre and post-procedure, decrease in oxygen saturation post-procedure, and duration of crying) are described using the mean, standard deviation and range; experimental vs control groups were compared with a Student's t-test. We assessed the equality of variances by using Levene's test and applied the result of the Student's t-test accordingly. Sex, the presence of crying, and adverse effects between the two groups are presented in percentages and compared using Fisher's exact test. Statistical significance was set for a p \<0.05. To perform statistical analyses we used STATA version 16.1 (StataCorp, College Station, TX, USA).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Pain
Ankyloglossia
Neonate
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
A blinded observer assessed pain by means of the Neonatal Infant Pain Scale (NIPS) score, crying duration, and whether there was a change in heart rate (HR) and/or in oxygen saturation (satO2) before and after the procedure.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lavender essential oil
Patients were swaddled, were given 1 mL of oral sucrose, and we let them suck for 2 minutes prior to the procedure. We placed a 7 x 7 cm gauze pad with 1 drop (43.75 mg) of 100% pure LEO (Pranarôm España S.L.) 2 cm under their nose for 2 minutes prior to starting the frenotomy and for the duration of the procedure.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Colostrum
Patients were swaddled, were given 1 mL of oral sucrose, and we let them suck for 2 minutes prior to the procedure. We placed a 7 x 7 cm gauze pad with 2 drops of their mother's colostrum 2 cm under their nose for 2 minutes prior to starting the frenotomy and for the duration of the procedure.
Group Type
EXPERIMENTAL
Colostrum
Intervention Type
BIOLOGICAL
Use of the patient's mother's inhaled colostrum during the frenotomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Colostrum
Use of the patient's mother's inhaled colostrum during the frenotomy
Intervention Type
BIOLOGICAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy full-term neonates born at our center or less than 15 days old referred for a frenotomy, who had ankyloglossia according to the Hazelbaker tool who were breastfed
Exclusion Criteria
* Denial of the patient's parents to participate
Minimum Eligible Age
1 Hour
Maximum Eligible Age
15 Days
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parc de Salut Mar
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Silvia Maya-Enero, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital del Mar
Barcelona, , Spain
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Spain
References
Explore related publications, articles, or registry entries linked to this study.
Ors R, Ozek E, Baysoy G, Cebeci D, Bilgen H, Turkuner M, Basaran M. Comparison of sucrose and human milk on pain response in newborns. Eur J Pediatr. 1999 Jan;158(1):63-6. doi: 10.1007/s004310051011.
Reference Type
RESULT
Goubet N, Strasbaugh K, Chesney J. Familiarity breeds content? Soothing effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2007 Jun;28(3):189-94. doi: 10.1097/dbp.0b013e31802d0b8d.
Reference Type
RESULT
Leng HY, Zheng XL, Zhang XH, He HY, Tu GF, Fu Q, Shi SN, Yan L. Combined non-pharmacological interventions for newborn pain relief in two degrees of pain procedures: A randomized clinical trial. Eur J Pain. 2016 Jul;20(6):989-97. doi: 10.1002/ejp.824. Epub 2015 Dec 18.
Reference Type
RESULT
Walter-Nicolet E, Annequin D, Biran V, Mitanchez D, Tourniaire B. Pain management in newborns: from prevention to treatment. Paediatr Drugs. 2010 Dec 1;12(6):353-65. doi: 10.2165/11318900-000000000-00000.
Reference Type
RESULT
Marlier L, Gaugler C, Messer J. Olfactory stimulation prevents apnea in premature newborns. Pediatrics. 2005 Jan;115(1):83-8. doi: 10.1542/peds.2004-0865.
Reference Type
BACKGROUND
Vaziri F, Khosropoor M, Hidari M, Pourahmad S, Morshed Behbahani B, Saki F. The Effect of Aromatherapy by Lavender Oil on Infant Vaccination Pain: a Double Blind Randomized Controlled Trial. J Caring Sci. 2019 Mar 1;8(1):17-21. doi: 10.15171/jcs.2019.003. eCollection 2019 Mar.
Reference Type
BACKGROUND
Cetinkaya B, Basbakkal Z. The effectiveness of aromatherapy massage using lavender oil as a treatment for infantile colic. Int J Nurs Pract. 2012 Apr;18(2):164-9. doi: 10.1111/j.1440-172X.2012.02015.x.
Reference Type
BACKGROUND
Burns E, Blamey C, Ersser SJ, Lloyd AJ, Barnetson L. The use of aromatherapy in intrapartum midwifery practice an observational study. Complement Ther Nurs Midwifery. 2000 Feb;6(1):33-4. doi: 10.1054/ctnm.1999.0901.
Reference Type
BACKGROUND
Habanananda T. Non-pharmacological pain relief in labour. J Med Assoc Thai. 2004 Oct;87 Suppl 3:S194-202.
Reference Type
BACKGROUND
Lopez V, Nielsen B, Solas M, Ramirez MJ, Jager AK. Exploring Pharmacological Mechanisms of Lavender (Lavandula angustifolia) Essential Oil on Central Nervous System Targets. Front Pharmacol. 2017 May 19;8:280. doi: 10.3389/fphar.2017.00280. eCollection 2017.
Reference Type
BACKGROUND
Akcan E, Polat S. Comparative Effect of the Smells of Amniotic Fluid, Breast Milk, and Lavender on Newborns' Pain During Heel Lance. Breastfeed Med. 2016 Aug;11(6):309-314. doi: 10.1089/bfm.2015.0174. Epub 2016 Jun 17.
Reference Type
BACKGROUND
Goubet N, Rattaz C, Pierrat V, Bullinger A, Lequien P. Olfactory experience mediates response to pain in preterm newborns. Dev Psychobiol. 2003 Mar;42(2):171-80. doi: 10.1002/dev.10085.
Reference Type
BACKGROUND
Harrison D, Larocque C, Bueno M, Stokes Y, Turner L, Hutton B, Stevens B. Sweet Solutions to Reduce Procedural Pain in Neonates: A Meta-analysis. Pediatrics. 2017 Jan;139(1):e20160955. doi: 10.1542/peds.2016-0955. Epub 2016 Dec 16.
Reference Type
BACKGROUND
Blass EM, Miller LW. Effects of colostrum in newborn humans: dissociation between analgesic and cardiac effects. J Dev Behav Pediatr. 2001 Dec;22(6):385-90. doi: 10.1097/00004703-200112000-00006.
Reference Type
BACKGROUND
Bellieni CV, Buonocore G, Nenci A, Franci N, Cordelli DM, Bagnoli F. Sensorial saturation: an effective analgesic tool for heel-prick in preterm infants: a prospective randomized trial. Biol Neonate. 2001 Jul;80(1):15-8. doi: 10.1159/000047113.
Reference Type
BACKGROUND
Bellieni CV, Bagnoli F, Perrone S, Nenci A, Cordelli DM, Fusi M, Ceccarelli S, Buonocore G. Effect of multisensory stimulation on analgesia in term neonates: a randomized controlled trial. Pediatr Res. 2002 Apr;51(4):460-3. doi: 10.1203/00006450-200204000-00010.
Reference Type
BACKGROUND
Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.
Reference Type
BACKGROUND
Ludington-Hoe SM, Hosseini R, Torowicz DL. Skin-to-skin contact (Kangaroo Care) analgesia for preterm infant heel stick. AACN Clin Issues. 2005 Jul-Sep;16(3):373-87. doi: 10.1097/00044067-200507000-00010.
Reference Type
BACKGROUND
Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. doi: 10.1001/archpedi.157.11.1084.
Reference Type
BACKGROUND
Gray L, Watt L, Blass EM. Skin-to-skin contact is analgesic in healthy newborns. Pediatrics. 2000 Jan;105(1):e14. doi: 10.1542/peds.105.1.e14.
Reference Type
BACKGROUND
Blass EM, Hoffmeyer LB. Sucrose as an analgesic for newborn infants. Pediatrics. 1991 Feb;87(2):215-8.
Reference Type
BACKGROUND
Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016 Jul 16;7(7):CD001069. doi: 10.1002/14651858.CD001069.pub5.
Reference Type
BACKGROUND
Blass EM, Ciaramitaro V. A new look at some old mechanisms in human newborns: taste and tactile determinants of state, affect, and action. Monogr Soc Res Child Dev. 1994;59(1):I-V, 1-81.
Reference Type
BACKGROUND
Field T, Goldson E. Pacifying effects of nonnutritive sucking on term and preterm neonates during heelstick procedures. Pediatrics. 1984 Dec;74(6):1012-5.
Reference Type
BACKGROUND
Fitri SYR, Wardhani V, Rakhmawati W, Pahria T, Hendrawati S. Culturally Based Practice in Neonatal Procedural Pain Management: A Mini Review. Front Pediatr. 2020 Sep 3;8:540. doi: 10.3389/fped.2020.00540. eCollection 2020.
Reference Type
BACKGROUND
Razaghi N, Aemmi SZ, Sadat Hoseini AS, Boskabadi H, Mohebbi T, Ramezani M. The effectiveness of familiar olfactory stimulation with lavender scent and glucose on the pain of blood sampling in term neonates: A randomized controlled clinical trial. Complement Ther Med. 2020 Mar;49:102289. doi: 10.1016/j.ctim.2019.102289. Epub 2019 Dec 26.
Reference Type
BACKGROUND
Franck LS, Lawhon G. Environmental and behavioral strategies to prevent and manage neonatal pain. Semin Perinatol. 1998 Oct;22(5):434-43. doi: 10.1016/s0146-0005(98)80059-1.
Reference Type
BACKGROUND
Simons SH, van Dijk M, Anand KS, Roofthooft D, van Lingen RA, Tibboel D. Do we still hurt newborn babies? A prospective study of procedural pain and analgesia in neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1058-64. doi: 10.1001/archpedi.157.11.1058.
Reference Type
BACKGROUND
Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Hubert P, de Saint Blanquat L, Boelle PY, Annequin D, Cimerman P, Anand KJ, Breart G. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008 Jul 2;300(1):60-70. doi: 10.1001/jama.300.1.60.
Reference Type
BACKGROUND
Mitchell A, Boss BJ. Adverse effects of pain on the nervous systems of newborns and young children: a review of the literature. J Neurosci Nurs. 2002 Oct;34(5):228-36. doi: 10.1097/01376517-200210000-00002.
Reference Type
BACKGROUND
Johnston C. Pain control in infants and young children. Pain Res Manag. 2011 Sep-Oct;16(5):320. doi: 10.1155/2011/505039. No abstract available.
Reference Type
BACKGROUND
Field T, Field T, Cullen C, Largie S, Diego M, Schanberg S, Kuhn C. Lavender bath oil reduces stress and crying and enhances sleep in very young infants. Early Hum Dev. 2008 Jun;84(6):399-401. doi: 10.1016/j.earlhumdev.2007.10.008. Epub 2007 Nov 28.
Reference Type
RESULT
Rattaz C, Goubet N, Bullinger A. The calming effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2005 Apr;26(2):86-92. doi: 10.1097/00004703-200504000-00003.
Reference Type
RESULT
Yilmaz F, Arikan D. The effects of various interventions to newborns on pain and duration of crying. J Clin Nurs. 2011 Apr;20(7-8):1008-17. doi: 10.1111/j.1365-2702.2010.03356.x. Epub 2010 Nov 5.
Reference Type
RESULT
Neshat H, Jebreili M, Seyyedrasouli A, Ghojazade M, Hosseini MB, Hamishehkar H. Effects of Breast Milk and Vanilla Odors on Premature Neonate's Heart Rate and Blood Oxygen Saturation During and After Venipuncture. Pediatr Neonatol. 2016 Jun;57(3):225-31. doi: 10.1016/j.pedneo.2015.09.004. Epub 2015 Oct 20.
Reference Type
RESULT
Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
Reference Type
RESULT
Karadede H, Mutlu B. The Effect of Swaddling and Oropharyngeal Colostrum During Endotracheal Suctioning on Procedural Pain and Comfort in Premature Neonates: A Randomized Controlled Trial. Adv Neonatal Care. 2024 Oct 1;24(5):466-474. doi: 10.1097/ANC.0000000000001190. Epub 2024 Aug 27.
Reference Type
RESULT
Nishitani S, Miyamura T, Tagawa M, Sumi M, Takase R, Doi H, Moriuchi H, Shinohara K. The calming effect of a maternal breast milk odor on the human newborn infant. Neurosci Res. 2009 Jan;63(1):66-71. doi: 10.1016/j.neures.2008.10.007. Epub 2008 Nov 1.
Reference Type
RESULT
Maya-Enero S, Fabregas-Mitjans M, Llufriu-Marques RM, Candel-Pau J, Garcia-Garcia J, Lopez-Vilchez MA. Comparison of the analgesic effect of inhaled lavender vs vanilla essential oil for neonatal frenotomy: a randomized clinical trial (NCT04867824). Eur J Pediatr. 2022 Nov;181(11):3923-3929. doi: 10.1007/s00431-022-04608-3. Epub 2022 Sep 8.
Reference Type
RESULT
Maya-Enero S, Fabregas-Mitjans M, Llufriu-Marques RM, Candel-Pau J, Garcia-Garcia J, Lopez-Vilchez MA. Analgesic effect of inhaled lavender essential oil for frenotomy in healthy neonates: a randomized clinical trial. World J Pediatr. 2022 Jun;18(6):398-403. doi: 10.1007/s12519-022-00531-7. Epub 2022 Apr 4.
Reference Type
RESULT
Slater R, Cornelissen L, Fabrizi L, Patten D, Yoxen J, Worley A, Boyd S, Meek J, Fitzgerald M. Oral sucrose as an analgesic drug for procedural pain in newborn infants: a randomised controlled trial. Lancet. 2010 Oct 9;376(9748):1225-32. doi: 10.1016/S0140-6736(10)61303-7.
Reference Type
RESULT
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023/10996
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants
NCT04487418
UNKNOWN
NA
Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.
NCT02141243
COMPLETED
NA
Efficacy of Neonatal Release of Ankyloglossia
NCT00967915
COMPLETED
NA
The Influence of Breastfeeding on Cortical Activity During Procedures
NCT03272594
COMPLETED
PHASE3
The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
NCT03097484
COMPLETED
PHASE3
Relevance of Veinous Lactates to Predict Postoperative Complications in Children 0-1 Years
NCT06909227
RECRUITING
Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants
NCT03268148
COMPLETED
NA
Breastfeeding Duration and Tongue-tie in Neonates.
NCT05946590
COMPLETED
NA
Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants
NCT00908401
UNKNOWN
PHASE3
The Use of Ketorolac in Surgical Neonates
NCT01667120
WITHDRAWN
PHASE2
Lingual Frenulum in Newborn Infants (LINNE)
NCT05560750
ACTIVE_NOT_RECRUITING
NA
The Scope of Tongue-tie in Norway: Its Prevalence and Consequences for Child Health
NCT04056936
UNKNOWN
Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm
NCT02133716
COMPLETED
PHASE4
Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT
NCT02146690
UNKNOWN
NA
Newborn Cortical Response to Pain and Non Pharmacological Analgesia
NCT03389789
COMPLETED
NA
Effect of Intact Umbilical Cord Milking on Neonatal and First Year Neurodevelopmental Outcomes in Very Preterm Infants.
NCT03200301
ACTIVE_NOT_RECRUITING
NA
A Study to Test the Pain-relieving Effect of Laughing Gas in Infants
NCT00250692
WITHDRAWN
PHASE3
Effect of Non-nutritive Sucking on Feeding Intolerance
NCT06065839
RECRUITING
NA
The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
NCT01866982
COMPLETED
NA
Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
NCT04062513
UNKNOWN
NA
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
NCT01536093
COMPLETED
PHASE2
Breast Milk vs Sucrose in Relieving Procedural Pain in Preterm Neonates During Blood Draw by Automated Heel Lance
NCT04898881
COMPLETED
PHASE4
Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Neurobehavior as Breast-Feeding Predictors
NCT01191970
WITHDRAWN
Interest of Using the Sevoflurane in the Prevention of Newborns Pain
NCT00420693
COMPLETED
PHASE2/PHASE3
Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture
NCT06200662
RECRUITING
NA