Is Inhaled Colostrum as Effective as Inhaled Lavender Essential Oil for Pain Control in Neonatal Frenotomies? A Prospective, Randomized Clinical Trial
Abstract
1. Introduction
2. Materials and Methods
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
LEO | Lavender essential oil |
NIPS | Neonatal Infant Pain Scale |
HR | Heart rate |
satO2 | Oxygen saturation |
SD | Standard deviation |
CI | Confidence interval |
Appendix A
Appearance Items | Score | Function Items | Score |
---|---|---|---|
Appearance of tongue when lifted | Lateralization | ||
Round or square | 2 | Complete | 2 |
Slight cleft in tip apparent | 1 | Body of tongue but not tongue tip | 1 |
Heart-shaped | 0 | None | 0 |
Elasticity of frenulum | Lift of tongue | ||
Very elastic (excellent) | 2 | Tip to mid-mouth | 2 |
Moderately elastic | 1 | Only edges to mid-mouth | 1 |
Little or no elasticity | 0 | Tip stays at alveolar ridge or rises to mid-mouth only with jaw closure | 0 |
Length of lingual frenulum when tongue lifted | Extension of tongue | ||
More than 1 cm or embedded in tongue | 2 | Tip over lower lip | 2 |
1 cm | 1 | Tip over lower gum only | 1 |
Less than 1 cm | 0 | Neither of the above, or anterior or midtongue humps | 0 |
Attachment of lingual frenulum to tongue | Spread of anterior tongue | ||
Posterior to tip | 2 | Complete | 2 |
At tip | 1 | Moderate or partial | 1 |
Notched tip | 0 | Little or none | 0 |
Attachment of lingual frenulum to inferior alveolar ridge | Cupping | ||
Attached to the floor of the mouth or well below the ridge | 2 | Entire edge, firm cup | 2 |
Attached just below the ridge | 1 | Side edges only, moderate cup | 1 |
Attached at ridge | 0 | Poor or no cup | 0 |
Total appearance score | Peristalsis | ||
Function items score
Frenotomy necessary if the Appearance item score is <8. | Complete, anterior to posterior (originates at the tip) | 2 | |
Partial: originating posterior to tip | 1 | ||
None or reverse | 0 | ||
Snapback | |||
None | 2 | ||
Periodic | 1 | ||
Frequent or with each suck | 0 | ||
Total function score |
Appendix B
Pain assessment | Score | |
---|---|---|
Facial expression | ||
0-Relaxed muscles | Restful face, neutral expression | |
1-Grimace | Tight facial muscles; furrowed brow, chin, jaw (negative facial expression – nose, mouth brow) | |
Cry | ||
0-No cry | Quiet, not crying | |
1-Whimper | Mild moaning, intermittent | |
2-Vigorous cry | Loud scream; rising, shrill, continuous (Note: silent cry may be scored if baby is intubated as evidenced by obvious mouth and facial movement) | |
Breathing pattern | ||
0-Relaxed | Usual pattern for this infant | |
1-Change in breathing | Indrawing, irregular, faster than usual; gagging, breath holding | |
Arms | ||
0-Relaxed/restrained | No muscular rigidity; occasional random movements of arms | |
1-Flexed/extended | Tense, straight arms; rigid and/or rapid extension, flexion | |
Legs | ||
0-Relaxed/restrained | No muscular rigidity; occasional random movements of legs | |
1-Flexed/extended | Tense, straight legs; rigid and/or rapid extension, flexion | |
State of arousal | ||
0-Sleeping/awake | Quiet, peaceful, sleeping or alert, random leg movements | |
1-Fussy | Alert, restless and thrashing |
References
- Brena Escobar, D. Protocolo para el manejo del dolor en Pediatría [Protocol for the pain management in pediatrics]. Rev. Med. Electrón. 2009, 31, 1684–1824. Available online: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1684-18242009000100008&lng=es&nrm=iso (accessed on 11 November 2024). (In Spanish).
- Urso, A.M. The reality of neonatal pain and the resulting effects. J. Neonatal Nurs. 2007, 13, 236–238. [Google Scholar] [CrossRef]
- Narbona López, E.; Contreras Chova, F.; García Iglesias, F.; Miras Baldo, M.J. Manejo del Dolor en el Recién Nacido [Newborn Pain Management]. Asociación Española de Pediatría [Spanish Association of Pediatrics]. 2008. Available online: https://www.aeped.es/sites/default/files/documentos/49.pdf (accessed on 11 November 2024).
- Johnston, C.C.; Fernandes, A.M.; Campbell-Yeo, M. Pain in neonates is different. Pain 2011, 152, S65–S73. [Google Scholar] [CrossRef]
- Mitchell, A.; Boss, B.J. Adverse effects of pain on the nervous systems of newborns and young children: A review of the literature. J. Neurosci. Nurs. 2002, 34, 228–236. [Google Scholar] [CrossRef]
- Walter-Nicolet, E.; Annequin, D.; Biran, V.; Mitanchez, D.; Tourniaire, B. Pain management in newborns: From prevention to treatment. Paediatr. Drugs 2010, 12, 353–365. [Google Scholar] [CrossRef]
- Carbajal, R.; Rousset, A.; Danan, C.; Coquery, S.; Nolent, P.; Ducrocq, S.; Saizou, C.; Lapillonne, A.; Granier, M.; Durand, P.; et al. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA 2008, 300, 60–70. [Google Scholar] [CrossRef]
- Simons, S.H.; van Dijk, M.; Anand, K.S.; Roofthooft, D.; van Lingen, R.A.; Tibboel, D. Do we still hurt newborn babies? A prospective study of procedural pain and analgesia in neonates. Arch. Pediatr. Adolesc. Med. 2003, 157, 1058–1064. [Google Scholar] [CrossRef]
- Parry, S. Acute pain management in the neonate. Anaesth. Intensive Care Med. 2006, 9, 147–151. [Google Scholar] [CrossRef]
- Franck, L.S.; Lawhon, G. Environmental and behavioral strategies to prevent and manage neonatal pain. Semin. Perinatol. 1998, 22, 434–443. [Google Scholar] [CrossRef]
- Razaghi, N.; Aemmi, S.Z.; Sadat Hoseini, A.S.; 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, 49, 102289. [Google Scholar] [CrossRef]
- Fitri, S.Y.R.; Wardhani, V.; Rakhmawati, W.; Pahria, T.; Hendrawati, S. Culturally Based Practice in Neonatal Procedural Pain Management: A Mini Review. Front. Pediatr. 2020, 8, 540. [Google Scholar] [CrossRef]
- Leng, H.Y.; Zheng, X.L.; Zhang, X.H.; He, H.Y.; Tu, G.F.; Fu, Q.; Shi, S.N.; Yan, L. Combined non-pharmacological interventions for newborn pain relief in two degrees of pain procedures: A randomized clinical trial. Eur. J. Pain 2016, 20, 989–997. [Google Scholar] [CrossRef]
- Goubet, N.; Strasbaugh, K.; Chesney, J. Familiarity breeds content? Soothing effect of a familiar odor on full-term newborns. J. Dev. Behav. Pediatr. 2007, 28, 189–194. [Google Scholar] [CrossRef]
- Razaghi, N.; Sadat Hoseini, A.; Aemmi, S.; Mohebbi, T.; Boskabadi, H. The Effects of Lavender Scent on Pain of Blood Sampling in Term Neonates. Int. J. Pediatr. 2015, 3, 535–541. [Google Scholar] [CrossRef]
- Field, T.; Goldson, E. Pacifying effects of nonnutritive sucking on term and preterm neonates during heelstick procedures. Pediatrics 1984, 74, 1012–1015. [Google Scholar] [CrossRef]
- Blass, E.M.; 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, 1–81. [Google Scholar] [CrossRef]
- Stevens, B.; Yamada, J.; Ohlsson, A.; Haliburton, S.; Shorkey, A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst. Rev. 2016, 7, CD001069. [Google Scholar] [CrossRef]
- Blass, E.M.; Hoffmeyer, L.B. Sucrose as an analgesic for newborn infants. Pediatrics 1991, 87, 215–218. [Google Scholar] [CrossRef]
- Gray, L.; Watt, L.; Blass, E.M. Skin-to-skin contact is analgesic in healthy newborns. Pediatrics 2000, 105, e14. [Google Scholar] [CrossRef]
- Johnston, C.C.; 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, 157, 1084–1088. [Google Scholar] [CrossRef]
- Ludington-Hoe, S.M.; Hosseini, R.; Torowicz, D.L. Skin-to-skin contact (Kangaroo Care) analgesia for preterm infant heel stick. AACN Clin. Issues 2005, 16, 373–387. [Google Scholar] [CrossRef]
- Gray, L.; Miller, L.W.; Philipp, B.L.; Blass, E.M. Breastfeeding is analgesic in healthy newborns. Pediatrics 2002, 109, 590–593. [Google Scholar] [CrossRef]
- Carbajal, R.; Veerapen, S.; Couderc, S.; Jugie, M.; Ville, Y. Analgesic effect of breast feeding in term neonates: Randomised controlled trial. BMJ 2003, 326, 13. [Google Scholar] [CrossRef]
- Bellieni, C.V.; Bagnoli, F.; Perrone, S.; Nenci, A.; Cordelli, D.M.; Fusi, M.; Ceccarelli, S.; Buonocore, G. Effect of multisensory stimulation on analgesia in term neonates: A randomized controlled trial. Pediatr. Res. 2002, 51, 460–463. [Google Scholar] [CrossRef]
- Bellieni, C.V.; Buonocore, G.; Nenci, A.; Franci, N.; Cordelli, D.M.; Bagnoli, F. Sensorial saturation: An effective analgesic tool for heel-prick in preterm infants: A prospective randomized trial. Biol. Neonate 2001, 80, 15–18. [Google Scholar] [CrossRef]
- Barr, R.G.; Young, S. A Two-Phase Model of the Soothing Taste Response: Implications for a Taste Probe of Temperament and Emotion Regulation; Lewis, M., Ramsay, D., Eds.; Soothing and Stress: Hillsdale, NJ, Earlbaum, 1999; pp. 109–137. [Google Scholar]
- Blass, E.M.; Miller, L.W. Effects of colostrum in newborn humans: Dissociation between analgesic and cardiac effects. J. Dev. Behav. Pediatr. 2001, 22, 385–390. [Google Scholar] [CrossRef]
- Ors, R.; Ozek, E.; Baysoy, G.; Cebeci, D.; Bilgen, H.; Türküner, M.; Başaran, M. Comparison of sucrose and human milk on pain response in newborns. Eur. J. Pediatr. 1999, 158, 63–66. [Google Scholar] [CrossRef]
- 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, 139, e20160955. [Google Scholar] [CrossRef]
- 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, 376, 1225–1232. [Google Scholar] [CrossRef]
- Maya-Enero, S.; Fàbregas-Mitjans, M.; Llufriu-Marquès, R.M.; Candel-Pau, J.; Garcia-Garcia, J.; López-Vílchez, M.Á. Analgesic effect of inhaled lavender essential oil for frenotomy in healthy neonates: A randomized clinical trial. World J. Pediatr. 2022, 18, 398–403. [Google Scholar] [CrossRef]
- Maya-Enero, S.; Fàbregas-Mitjans, M.; Llufriu-Marquès, R.M.; Candel-Pau, J.; Garcia-Garcia, J.; López-Vílchez, M.Á. Comparison of the analgesic effect of inhaled lavender vs vanilla essential oil for neonatal frenotomy: A randomized clinical trial (NCT04867824). Eur. J. Pediatr. 2022, 181, 3923–3929. [Google Scholar] [CrossRef]
- Goubet, N.; Rattaz, C.; Pierrat, V.; Bullinger, A.; Lequien, P. Olfactory experience mediates response to pain in preterm newborns. Dev. Psychobiol. 2003, 42, 171–180. [Google Scholar] [CrossRef]
- Rattaz, C.; Goubet, N.; Bullinger, A. The calming effect of a familiar odor on full-term newborns. J. Dev. Behav. Pediatr. 2005, 26, 86–92. [Google Scholar] [CrossRef]
- 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, 63, 66–71. [Google Scholar] [CrossRef]
- McNair, C.; Campbell-Yeo, M.; Johnston, C.; Taddio, A. Nonpharmacologic Management of Pain During Common Needle Puncture Procedures in Infants: Current Research Evidence and Practical Considerations: An Update. Clin. Perinatol. 2019, 46, 709–730. [Google Scholar] [CrossRef]
- Hofer, M.A. Hidden regulators in attachment, separation, and loss. Monogr. Soc. Res. Child Dev. 1994, 59, 192–207. [Google Scholar] [CrossRef]
- 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, 11, 309–314. [Google Scholar] [CrossRef]
- 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, 24, 466–474. [Google Scholar] [CrossRef]
- Hazelbaker, A.K. The Assessment Tool for Lingual Frenulum Function: Use in a Lactation Consultant Private Practice; Pacific Oaks College: Pasadena, CA, USA, 1993. [Google Scholar]
- Lawrence, J.; Alcock, D.; McGrath, P.; Kay, J.; MacMurray, S.B.; Dulberg, C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993, 12, 59–66. [Google Scholar] [CrossRef]
- López, V.; Nielsen, B.; Solas, M.; Ramírez, M.J.; Jäger, A.K. Exploring Pharmacological Mechanisms of Lavender (Lavandula angustifolia) Essential Oil on Central Nervous System Targets. Front. Pharmacol. 2017, 8, 280. [Google Scholar] [CrossRef]
- Habanananda, T. Non-pharmacological pain relief in labour. J. Med. Assoc. Thai. 2004, 87 (Suppl. 3), S194–S202. [Google Scholar]
- Burns, E.; Blamey, C.; Ersser, S.J.; Lloyd, A.J.; Barnetson, L. The use of aromatherapy in intrapartum midwifery practice an observational study. Complement. Ther. Nurs. Midwifery 2000, 6, 33–34. [Google Scholar] [CrossRef]
- Çetinkaya, B.; Başbakkal, Z. The effectiveness of aromatherapy massage using lavender oil as a treatment for infantile colic. Int. J. Nurs. Pract. 2012, 18, 164–169. [Google Scholar] [CrossRef]
- Maddocks-Jennings, W.; Wilkinson, J.M. Aromatherapy practice in nursing: Literature review. J. Adv. Nurs. 2004, 48, 93–103. [Google Scholar] [CrossRef]
- Sadathosseini, A.S.; Negarandeh, R.; Movahedi, Z. The effect of a familiar scent on the behavioral and physiological pain responses in neonates. Pain Manag. Nurs. 2013, 14, e196–e203. [Google Scholar] [CrossRef]
- Badiee, Z.; Asghari, M.; Mohammadizadeh, M. The calming effect of maternal breast milk odor on premature infants. Pediatr. Neonatol. 2013, 54, 322–325. [Google Scholar] [CrossRef]
- Neshat, H.; Jebreili, M.; Seyyedrasouli, A.; Ghojazade, M.; Hosseini, M.B.; 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, 57, 225–231. [Google Scholar] [CrossRef]
- 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, 8, 17–21. [Google Scholar] [CrossRef]
- Yilmaz, F.; Arikan, D. The effects of various interventions to newborns on pain and duration of crying. J. Clin. Nurs. 2011, 20, 1008–1017. [Google Scholar] [CrossRef]
- 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, 84, 399–401. [Google Scholar] [CrossRef]
- Marlier, L.; Gaugler, C.; Messer, J. Olfactory stimulation prevents apnea in premature newborns. Pediatrics 2005, 115, 83–88. [Google Scholar] [CrossRef]
Experimental Group n = 71 (%) | Control Group n = 71 (%) | p-Value | |
---|---|---|---|
Male newborn | 38 (53.5) | 46 (64.8) | 0.23 a |
Female newborn | 33 (46.5) | 25 (35.2) | |
Ratio ♂:♀ | 2.1:1 | 2.8:1 | |
Birth weight (grams) (mean, SD) (range) | 3310.4 (478.6) | 3341.1 (457.9) | 0.69 b |
(2026–4502) | (2138–4106) | ||
Gestational age (weeks) (mean, SD) (range) | 395/7 (12/7) | 394/7 (12/7) | 0.55 b |
371/7–422/7 | 370/7–416/7 | ||
Age at frenotomy (hours) (mean, SD) (range) | 72.3 (76.8) (5–360) | 59.8 (78.8) (5–360) | 0.34 b |
Experimental Group n = 71 (%) | Control Group n = 71 (%) | p-Value | |
---|---|---|---|
Heart rate (bpm) pre-procedure (mean, SD) (range) post-procedure (mean, SD) (range) | 130.0 (17.2) (93–168) 164.0 (19.6) (84–202) | 131.5 (18.3) (88–180) 162.5 (21.3) (20–203) | 0.63 b 0.66 b |
Increase in heart rate post-procedure (bpm) (mean, SD) (range) | 33.9 (20.4) (−20;+87) | 31.0 (19.4) (−18;+80) | 0.38 b |
Oxygen saturation (%) pre-procedure (mean, SD) (range) post-procedure (mean, SD) (range) | 99.5 (1.1) (95–100) 95.8 (3.3) (84–100) | 99.3 (1.1) (95–100) 94.8 (4.9) (77–100) | 0.46 b 0.16 b |
Decrease in oxygen saturation post-procedure (%) (mean, SD) (range) | −3.6 (3.2) (0;−16) | −4.5 (4.9) (+1;−23) | 0.22 b |
Crying (seconds) (mean, SD) (range) | 28.0 (24.4) (1–150) | 40.2 (39.4) (0–182) | 0.03 b |
Presence of adverse effects (yes, %) | 0 (0.0%) | 0 (0.0%) | - |
NIPS score (mean, SD) (range) | 1.4 (0.8) (0–5) | 1.5 (0.8) (0–3) | 0.28 b |
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Maya-Enero, S.; Candel-Pau, J.; Valle-Del Barrio, B.; Fàbregas-Mitjans, M.; Prieto-Paja, S.; López-Vílchez, M.Á. Is Inhaled Colostrum as Effective as Inhaled Lavender Essential Oil for Pain Control in Neonatal Frenotomies? A Prospective, Randomized Clinical Trial. Children 2025, 12, 982. https://doi.org/10.3390/children12080982
Maya-Enero S, Candel-Pau J, Valle-Del Barrio B, Fàbregas-Mitjans M, Prieto-Paja S, López-Vílchez MÁ. Is Inhaled Colostrum as Effective as Inhaled Lavender Essential Oil for Pain Control in Neonatal Frenotomies? A Prospective, Randomized Clinical Trial. Children. 2025; 12(8):982. https://doi.org/10.3390/children12080982
Chicago/Turabian StyleMaya-Enero, Silvia, Júlia Candel-Pau, Beatriz Valle-Del Barrio, Montserrat Fàbregas-Mitjans, Sandra Prieto-Paja, and María Ángeles López-Vílchez. 2025. "Is Inhaled Colostrum as Effective as Inhaled Lavender Essential Oil for Pain Control in Neonatal Frenotomies? A Prospective, Randomized Clinical Trial" Children 12, no. 8: 982. https://doi.org/10.3390/children12080982
APA StyleMaya-Enero, S., Candel-Pau, J., Valle-Del Barrio, B., Fàbregas-Mitjans, M., Prieto-Paja, S., & López-Vílchez, M. Á. (2025). Is Inhaled Colostrum as Effective as Inhaled Lavender Essential Oil for Pain Control in Neonatal Frenotomies? A Prospective, Randomized Clinical Trial. Children, 12(8), 982. https://doi.org/10.3390/children12080982