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Pain Response in Newborns to the Order of Injecting BCG and Hepatitis-B Vaccines: A Randomized Trial

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Abstract

Objective

To determine if acute pain response after administration of the BCG vaccine and the Hepatitis-B vaccine is affected by the order in which they are given.

Methods

This Single-center randomized clinical trial was conducted in the Vaccination room in the Pediatrics Outpatient Department at KVG Medical College; Karnataka, India. 76 healthy term neonates undergoing routine immunization were included in this study. Newborns received either BCG vaccine or the Hepatitis-B vaccine first, followed by the other vaccine. The primary outcome was neonatal pain during vaccine injection as assessed by a validated measure, the Neonatal Infant Pain Scale (NIPS), scored by resident doctors blinded to the study purpose and hypothesis. In addition, a nurse rated pain using a 10-cm visual analog scale(VAS).

Results

A total of 76 infants participated: 38 received the BCG vaccine first and 38 received the Hepatitis-B vaccine first. Demographic characteristics did not differ between the groups. Overall mean (SD) pain scores per neonate were significantly lower when BCG was administered first compared to the order when Hepatitis-B vaccine was administered first (for NIPS 5.55 [0.54] vs. 5.84 [0.29], P = .005; for VAS, 6.25 [0.80] vs. 6.58 [0.54], P = .04). When given first, the BCG vaccine caused significantly less pain (P < .001)than the Hepatitis-B, as assessed by the NIPS and VAS (P < .001).

Conclusions

Pain was reduced when the BCG vaccine was administered before the Hepatitis-B in neonates undergoing routine vaccination. The authors recommend that the order of vaccine injections be the BCG vaccine followed by Hepatitis-B.

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Contributions

SRR conceived the study, collected data and drafted the paper. PMJK and ADM revised the manuscript critically. ADM was also involved in designing the study. The final manuscript was approved by all authors.

Conflict of Interests

None.

Role of Funding Source

None.

Registration of Trial

Clinical Trials Registry - India, CTRI/2010/091/000426.

Author information

Authors and Affiliations

  1. Department of Pediatrics, KVG Medical College and Hospital, Sullia, Dakshina Kannada, Karnataka, India, 574327

    S. R. Ravikiran

  2. Department of Pediatrics, KVG Medical College, Sullia, Dakshina Kannada, Karnataka, India, 574327

    P. M. Jagadeesh Kumar

  3. Department of Community Medicine, KVG Medical College, Sullia, Dakshina Kannada, Karnataka, India, 574327

    Anand D. Meundi

Authors
  1. S. R. Ravikiran
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  2. P. M. Jagadeesh Kumar
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  3. Anand D. Meundi
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Corresponding author

Correspondence to S. R. Ravikiran.

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Ravikiran, S.R., Kumar, P.M.J. & Meundi, A.D. Pain Response in Newborns to the Order of Injecting BCG and Hepatitis-B Vaccines: A Randomized Trial. Indian J Pediatr 78, 693–697 (2011). https://doi.org/10.1007/s12098-010-0327-3

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  • DOI: https://doi.org/10.1007/s12098-010-0327-3

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