Use of Inhaled Colostrum to Control Pain in Neonatal Frenotomy and Comparison to Inhaled Lavender Essential Oil

NCT06869902 | Completed

• 1 other identifier: 2023/10996
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Ankyloglossia; Neonate

Keywords

ankyloglossia; lavender; colostrum; pain

Outcome Measures

Primary Outcomes (3)

• Increase in heart rate

  Increase in heart rate before and after the procedure

  Immediately before the technique and up to 5 minutes after completing it

• Oxygen saturation

  Decrease in oxygen saturation before and after the procedure

  Immediately before the technique and up to 5 minutes after completing it

• NIPS score

  Assessment of the highest Neonatal Infant Pain Scale (NIPS) score

  Immediately before the technique and up to 5 minutes after completing it

Study Arms (2)

Lavender essential oil

NO INTERVENTION

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.

Colostrum

EXPERIMENTAL

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.

Biological: Colostrum

Interventions

Colostrum BIOLOGICAL

Use of the patient's mother's inhaled colostrum during the frenotomy

Colostrum

Eligibility Criteria

• Age: 1 Hour - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Denial of the patient's parents to participate

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (41)

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MeSH Terms

Conditions

Pain; Ankyloglossia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stomatognathic Diseases

Study Officials

• Silvia Maya-Enero, PhD, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: September 18, 2023
• Primary Completion: June 14, 2024
• Study Completion: June 30, 2024
• Last Updated: March 11, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)