Efficacy of Skin-to-Skin Care versus Swaddling for Pain Control Associated with Vitamin K Administration in Full-Term Neonates: A Randomized Controlled Trial

Dipen V Patel; Sarthak N Soni; Vivek V Shukla; Ajay G Phatak; Mayur K Shinde; Archana S Nimbalkar; Somashekhar M Nimbalkar

doi:10.1093/tropej/fmac052

Efficacy of Skin-to-Skin Care versus Swaddling for Pain Control Associated with Vitamin K Administration in Full-Term Neonates: A Randomized Controlled Trial

J Trop Pediatr. 2022 Jun 6;68(4):fmac052. doi: 10.1093/tropej/fmac052.

Authors

Dipen V Patel¹, Sarthak N Soni², Vivek V Shukla^{1

3}, Ajay G Phatak⁴, Mayur K Shinde⁴, Archana S Nimbalkar⁵, Somashekhar M Nimbalkar¹

Affiliations

¹ Department of Neonatology, Pramukhswami Medical College, Bhaikaka University, Karamsad, India.
² Department of Pediatrics, Pramukhswami Medical College, Bhaikaka University, Karamsad, India.
³ Division of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.
⁴ Central Research Services, Pramukhswami Medical College, Charutar Arogya Mandal, Bhaikaka University, Karamsad, India.
⁵ Department of Physiology, Pramukhswami Medical College, Bhaikaka University, Charutar Arogya Mandal, Karamsad, India.

PMID: 35737952
DOI: 10.1093/tropej/fmac052

Abstract

Objective: The objective of the study was to assess the efficacy of immediate skin-to-skin care (SSC) versus swaddling in pain response to intramuscular injection of vitamin K at 30 min of birth in neonates.

Methods: Healthy full-term newborns were enrolled immediately after normal vaginal delivery and randomized in two groups, SSC and swaddling. Neonatal Infant Pain Scale (NIPS) was measured before, immediately after and at 2 min after the injection.

Results: Total 100 newborns were enrolled in the study (50 in each group). The mean (SD) birth weight of newborns in the SSC and swaddling group was 2668 (256) and 2730 (348) g, respectively. NIPS was comparable between the SSC and swaddling at before [1.78 (0.58) vs. 1.96 (0.83), p = 0.21], and immediately after the injection [4.82 (0.72) vs. 5.08 (0.75), p = 0.08]. NIPS at 2 min after the injection was significantly low in the SSC group compared to the swaddling group [1.38 (0.70) vs. 2.88 (1.00), p < 0.001]. At 2 min after injection, the NIPS score was significantly lower than baseline in the SSC group (p = 0.002), while it was significantly higher in the swaddling group (p < 0.001). A significantly higher proportion of newborns had a NIPS score of more than three at 2 min after injection in the swaddling group as compared to the SSC group (22% vs. 2%, p < 0.001).

Conclusion: Immediate SSC was more efficacious as compared to swaddling as a pain control intervention while giving vitamin K injection.

Clinical trial registration: The trial is registered with the Clinical Trial Registry of India with Registration number: CTRI/2020/01/022984.

Keywords: Neonatal Infant Pain Scale; injections; skin-to-skin care; swaddling.

Plain language summary

Skin-to-skin care and swaddling are commonly used non-pharmacological measures to reduce pain perception in neonates for invasive procedures like heel prick, venipuncture and vaccination. We did this randomized control trial to compare the efficacy of immediate skin-to-skin care after birth vs. swaddling for reducing neonatal pain associated with intramuscular injection of vitamin K at 30 min after birth. We observed that the immediate skin-to-skin care, a standard of care, is more efficacious in controlling pain compared to swaddling for giving routine intramuscular vitamin K injection within one hour of birth.

Publication types

Randomized Controlled Trial

MeSH terms

Female
Humans
Infant, Newborn
Injections, Intramuscular
Pain / drug therapy
Pain / etiology
Pain / prevention & control
Pain Management*
Skin Care
Vitamin K*

Substances

Vitamin K

Associated data

CTRI/CTRI/2020/01/022984