The Indian Journal of Pediatrics

, Volume 84, Issue 5, pp 357–363 | Cite as

Methodological Study to Develop Standard Operational Protocol on Oral Drug Administration for Children

  • Sunil Kumar Bijarania
  • Sushma Kumari Saini
  • Sanjay Verma
  • Sukhwinder Kaur
Original Article



To develop standard operational protocol (SOP) on oral drug administration and checklist to assess the implementation of the developed SOP.


In this prospective methodological study, SOPs were developed in five phases. In the first phase, the preliminary draft of SOPs and checklists were prepared based on literature review, assessment of current practices and focus group discussion (FGD) with bedside working nurses. In the second phase, content validity was checked with the help of Delphi technique (12 experts). Total four drafts were prepared in stages and necessary modifications were made as per suggestions after each Delphi round. Fourth Delphi round was performed after conducting a pilot study. In the fourth phase, all bedside nurses were trained as per SOPs and asked to practice accordingly and observation of thirty oral drug administrations in children was done to check reliability of checklists for implementation of SOPs. In Phase-V, 7 FGDs were conducted with bedside nurses to assess the effectiveness of SOPs.


The Content Validity Index (CVI) of SOP and checklists was 99.77%. Overall standardized Cronbach’s alpha was calculated as 0.94. All the nurses felt that the SOP is useful.


Valid and feasible SOP for drug administration to children through oral route along with valid and reliable checklist were developed. It is recommended to use this document for drug administration to children.


SOP Delphi-technique CVI FGD 



SKS helped in drafting, critical revision and finalization of the manuscript. SKS, SV, SK contributed to the study design, data collection, analysis and interpretation, and also critically reviewed the manuscript. SKB finalized the manuscript and shall act as the overall guarantor.

Compliance with Ethical Standards

Conflict of Interest


Source of Funding



  1. 1.
    Stup R. Standard operating procedures: a writing guide. Dairy Alliance, Penn state university, 2001. Available at: organizational dev/SOPManual.pdf. Accessed on 10 Nov 2014.
  2. 2.
    Bedi S, Behera SD, Arya SK, Singh S. Standard operating procedures in hospitals- a reality check. J Acad Hosp Adm. 2006;18:1–7.Google Scholar
  3. 3.
    Bianca A, Demand M. The importance of standard operating procedures in organizations. Houston chronicle, 2014. Available at: Accessed on 10 Nov 2014.
  4. 4.
    Geake BG, Williams P. Administration of medicines – clinical calculations assessment for registered nurses policy. 2012 August; [9 screens) Available at:–%20Clinical%20Calculations%20Assessment%20for%20Registered%20Nurses%20Policy.pdf. Accessed on 10 Nov 2014.
  5. 5.
    Chaboyer W, Murray AM, Wallis M. Standard operating protocol for implementing bedside handover in nursing. Centre-health-practice-innovation, 2008;1–20. Available at: Accessed on 10 Nov 2014.
  6. 6.
    Tissot E, Cornette C, Limat S, et al. Observational study of potential risk factors of medication administration errors. Pharm World Sci. 2003;25:264–8.CrossRefPubMedGoogle Scholar
  7. 7.
    Chua S, Chua H, Omar A. Drug administration errors in paediatric wards: a direct observation approach. Eur J Pediatr. 2009;169:603–11.CrossRefPubMedGoogle Scholar
  8. 8.
    Ross L. Medication errors in a paediatric teaching hospital in the UK: five years operational experience. Arch Dis Child. 2000;83:492–7.CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    Greig L, Sudworth A. Administration of medications and fluids via a peripheral intravenous cannula. Scottish Diabetes Research Network. 2013;22:1–6. Available at: Accessed on 16 Jan 2016.
  10. 10.
    Cameron J. Focusing on the focus group. In: Hay I, editor. Qualitative research methods in human geography. 2nd ed. Melbourne: Oxford University Press; 2005.Google Scholar
  11. 11.
    Wong LP. Focus group discussion: a tool for health and medical research. Singap Med J. 2008;49:256–61.Google Scholar
  12. 12.
    Krueger RA. Focus groups: a practical guide for applied research. 3rd ed. Newbury Park: Sage Publications; 1988.Google Scholar
  13. 13.
    Hsu CC, Sandford BA. The Delphi technique: making sense of consensus. PARE. 2007;12:1–8. ISSN 1531-7714Google Scholar
  14. 14.
    Gil B, Ezama DP. The Delphi method as a technique to study validity of content. Ann Psychol. 2012;28:103–12.Google Scholar
  15. 15.
    Kaushal RK, Kapoor S, Kaur S, Bhagat H. A methodological study to develop a ‘nursing checklist’ for receiving patients in ICUs. Nurs Midwifery Res J. 2015;11:1–11.Google Scholar
  16. 16.
    D’Souza SRB, Kumar V, Lewis LE. Development of a tool for assessing preterm infants. Nurs Midwifery Res J. 2014;10:91–9.Google Scholar
  17. 17.
    George L, Kaur S, Rao KLN. Development of a nursing care protocol for care of neonates with esophageal atresia/tracheo-esophageal fistula. Nurs Midwifery Res J. 2014;10:106–19.Google Scholar
  18. 18.
    Tavakol M, Dennick R. Making sense of Cronbach’s alpha. Int J Med Educ. 2011;2:53–5.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Dr. K C Chaudhuri Foundation 2017

Authors and Affiliations

  • Sunil Kumar Bijarania
    • 1
  • Sushma Kumari Saini
    • 1
  • Sanjay Verma
    • 2
  • Sukhwinder Kaur
    • 1
  1. 1.National Institute of Nursing Education, Postgraduate Institute of Medical Education and ResearchChandigarhIndia
  2. 2.Department of Pediatric MedicinePostgraduate Institute of Medical Education and ResearchChandigarhIndia

Personalised recommendations