Vaccine related reactogenicity for primary immunization: a randomized controlled trial of 23(wider) vs. 25(narrower) gauge needles with same lengths.
OBJECTIVE
To compare vaccine related reactogenicity during primary immunization in healthy infants using 23 vs. 25 gauge needles.


METHODS
This randomized controlled trial was conducted in Vaccination Room of the Advanced Pediatrics Center. 155 participants for primary immunization were assigned to two intervention groups (23 vs. 25 gauge). Parent-reported local and systemic reactions were recorded daily for three days after the immunization.


RESULTS
Swelling (24%) and tenderness (21%) were the two most common parent-reported local symptoms followed by restriction of movements (18%) and redness (10%) on day 1. Any local reaction on day 1 was statistically similar in 25 gauge vs. 23 gauge group (RR 0.77; 95% CI: 0.32 to 1.82) (P = 0.54), but fever (day 1) showed higher trend in 23 gauge needle group (RR 2.24; 95% CI: 0.92-5.47) (P = 0.07). Furthermore, on analysis of serially reported local and systemic reactions for 3 consecutive days by generalized estimating equations, odds of redness, swelling, tenderness, restricted movement and fever were statistically similar between two needle groups. On the other hand, median (± SE) crying time (in seconds) was significantly prolonged in the 25 gauge needle (39 ± 2) as compared to 23 gauge group (30 ± 1.3) (log rank test, P = 0.001).


CONCLUSIONS
The use of same length needles with narrower (25) or wider (23) gauge did not show significant differences in local reactogenicity during primary immunization. Fever, however, was reduced marginally in 25 gauge group whereas crying duration was significantly shorter with 23 gauge needle. Finally, larger studies are needed to further evaluate objectively the outcome of reactogenicity.
Bharti
Bhavneet
B
Department of Pediatrics, Advanced Pediatrics Center, Postgraduate Institute of Medical Education & Research, Chandigarh, India. bhavneetb@yahoo.com
Grewal
Anjum
A
Kalia
Raman
R
Pathak
Pragya
P
D003448:Crying; D003875:Drug Eruptions / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects* / Q000295:instrumentation*; D007194:India; D007223:Infant; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D009339:Needles; D010146:Pain / Q000209:etiology / Q000517:prevention & control*
BMJ. 2000 Oct 14;321(7266):931-3
11030682
Pediatrics. 2007 May;119(5):e1184-98
17473085
Med Clin (Barc). 2002 Jan 19;118(1):1-4
11803003
BMJ. 2001 Feb 24;322(7284):492
11263435
BMJ. 2006 Sep 16;333(7568):571
16891328
Acta Paediatr. 2001 Nov;90(11):1329-36
11808908
Arch Pediatr Adolesc Med. 2009 May;163(5):469-72
19414694
Pediatrics. 2008 Mar;121(3):e646-52
18310184
J Nurs Scholarsh. 2008;40(3):219-25
18840204
Arch Dis Child. 2008 May;93(5):449-50
18426944