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.
Division of Pediatric Medicine and Pediatric Outcomes Research Team (PORT), Department of Pediatrics, Faculty of Medicine, University of Toronto, Canada. mm.ipp@utoronto.ca
Moshe
M
Ipp
Anna
A
Taddio
Jonathan
J
Sam
Morton
M
Gladbach
Patricia C
PC
Parkin
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