Vaccine-related pain: randomised controlled trial of two injection techniques.
OBJECTIVE
To compare acute pain response during immunisation in infants using a slow standard of care injection technique versus a rapid pragmatic technique.


METHODS
Randomised controlled trial.


METHODS
Single-centre, urban paediatric primary care practice.


METHODS
Healthy infants 4-6 months of age receiving their routine DPTaP-Hib immunisation.


METHODS
Standard of care group: slow aspiration prior to injection, slow injection and slow withdrawal. Pragmatic group: no aspiration, rapid injection and rapid withdrawal.


METHODS
Immediate infant pain measured by the Modified Behavior Pain Scale (MBPS), crying and parent/paediatrician visual analogue scale (VAS).


RESULTS
113 infants participated; there were no observed differences in age, birth order or prior analgesic use. Mean MBPS scores (95% confidence interval (CI)) were higher (p<0.001) for the standard group compared to the pragmatic group, 5.6 (5 to 6.3) vs 3.3 (2.6 to 3.9). The standard group was more likely to cry, 47/57 (82%) vs 24/56 (43%), to cry longer, median (interquartile range (IQR)) 14.7 s (8.7-35.6) vs 0 s (0-11.30), and to take longer to have the vaccine injected, median (IQR) 8.8 s (7.9-10.3) vs 0.9 s (0.8-1.1), p<0.001 for all comparisons. The median (IQR) VAS scores by parents and paediatricians were higher for the standard group: VAS parent, 3.5 (1.6-5.5) vs 1.9 (0.1-3.1) and VAS paediatrician, 2.8 (2.0-5.1) vs 1.4 (0.2-2.4). There were no adverse events.


CONCLUSIONS
Immunisation using a pragmatic rapid injection technique is less painful than a slow standard of care technique and should be recommended for routine intramuscular immunisations.
Ipp
Moshe
M
Division of Pediatric Medicine and Pediatric Outcomes Research Team (PORT), Department of Pediatrics, Faculty of Medicine, University of Toronto, Canada. mm.ipp@utoronto.ca
Taddio
Anna
A
Sam
Jonathan
J
Gladbach
Morton
M
Parkin
Patricia C
PC
D016667:Bacterial Capsules; D003448:Crying; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage; D006801:Humans; D007114:Immunization / Q000009:adverse effects* / Q000379:methods*; D007223:Infant; D007273:Injections, Intramuscular / Q000009:adverse effects / Q000379:methods; D008297:Male; D010146:Pain / Q000209:etiology* / Q000517:prevention & control; D010147:Pain Measurement / Q000379:methods; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage; D013396:Suction; D013997:Time Factors; D017778:Vaccines, Combined / Q000008:administration & dosage
D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined