Effect of needle length on incidence of local reactions to routine immunisation in infants aged 4 months: randomised controlled trial - PubMed (original) (raw)
Clinical Trial
Effect of needle length on incidence of local reactions to routine immunisation in infants aged 4 months: randomised controlled trial
L Diggle et al. BMJ. 2000.
Abstract
Objective: To compare rates of local reactions associated with two needle sizes used to administer routine immunisations to infants.
Design: Randomised controlled trial.
Setting: Routine immunisation clinics in eight general practices in Buckinghamshire.
Participants: Healthy infants attending for third primary immunisation due at 16 weeks of age: 119 infants were recruited, and 110 diary cards were analysed.
Interventions: Immunisation with 25 gauge, 16 mm, orange hub needle or 23 gauge, 25 mm, blue hub needle.
Main outcome measures: Parental recordings of redness, swelling, and tenderness for three days after immunisation.
Results: Rate of redness with the longer needle was initially two thirds the rate with the smaller needle (relative risk 0.66 (95% confidence interval 0.45 to 0.99), P=0.04), and by the third day this had decreased to a seventh (relative risk 0.13 (0.03 to 0.56), P=0.0006). Rate of swelling with the longer needle was initially about a third that with the smaller needle (relative risk 0.39 (0.23 to 0.67), P=0.0002), and this difference remained for all three days. Rates of tenderness were also lower with the longer needle throughout follow up, but not significantly (relative risk 0.60 (0.29 to 1.25), P=0.17).
Conclusions: Use of 25 mm needles significantly reduced rates of local reaction to routine infant immunisation. On average, for every five infants vaccinated, use of the longer needle instead of the shorter needle would prevent one infant from experiencing any local reaction. Vaccine manufacturers should review their policy of supplying the shorter needle in vaccine packs.
Figures
Figure
Flow chart describing randomisation sequence
Comment in
- ACP J Club. 2001 Jul-Aug;135(1):29
- Needle length and incidence of local reactions to immunisation. Is there a real benefit for the child?
Heininger U. Heininger U. BMJ. 2001 Feb 24;322(7284):492-3. BMJ. 2001. PMID: 11222435 No abstract available. - Needle length and incidence of local reactions to immunisation. How quickly can research change practice?
Platt J. Platt J. BMJ. 2001 Feb 24;322(7284):492. BMJ. 2001. PMID: 11222440 Free PMC article. No abstract available.
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References
- Department of Health. Immunisation against infectious diseases. London: HMSO; 1996.
- World Health Organisation. Immunisation in practice. Module 8. During a session: giving immunisations. Geneva: WHO; 1998. www.who.int/vaccines-documents/DoxTrng/H4IIP.htm . ( www.who.int/vaccines-documents/DoxTrng/H4IIP.htm (accessed 3 October 2000).) (accessed 3 October 2000).)
- Department of Health. Current vaccine issues: action update. London: DoH; 1999. . (Professional letter PL/CMO/99/5.)
- Diggle L. London: Royal College of Nursing Institute; 1999. A randomised controlled trial of different needle lengths on the incidence of local reactions when administering the combined injection of diphtheria/pertussis/tetanus (DPT) and Haemophilus influenzae type b (Hib) to infants at 4-months of age [dissertation]
- Mark A, Carlsson R, Granstrom M. Subcutaneous versus intramuscular injection for booster DT vaccination of adolescents. Vaccine. 1999;17:2067–2072. - PubMed
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