Cochrane · systematic review · CD010720

Needle size for vaccination procedures in children and adolescents

Beirne, PV, Hennessy, S, Cadogan, SL, et al. · Cochrane Database of Systematic Reviews · 2018 · Cochrane Library

Pain, Palliative and Supportive Care2 versionsAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
33
current version
GRADE rated
23
No studies
10
Included studies
NR
No studies 10 · 30.3%Ungraded 0 · 0%Very low 6 · 18.2%Low 2 · 6.1%Moderate 14 · 42.4%High 1 · 3%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Current version only

Comparison between needles with different lengths but with the same gauge

Population: infants aged approximately 2 to 6 months undergoing vaccination in the anterolateral thigh with a DTwP‐Hib vaccine
CD010720.PUB3 (current) · 11 questions
OutcomeEffectEvidenceStatus / GRADE
Incidence of diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib) (not measured)
no estimate extractedNRNo studies
2a. Adequate immune response (seroprotection) against diphtheria (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 312 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2b. Adequate immune response (seroprotection) against tetanus (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 390 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2c. Adequate immune response (seroprotection) against pertussis (not measured)
no estimate extractedNRNo studies
2d. Adequate immune response (seroprotection) against Haemophilus influenzae type b disease (surrogate outcome)
RR 1.1 [1.01, 1.2]1 study · 400 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Pain (not measured)
no estimate extractedNRNo studies
4a. Procedural crying (during and immediately after the vaccination procedure) (not measured)
no estimate extractedNRNo studies
4b. Persistent inconsolable crying4
RR 2.49 [0.49, 12.7]1 study · 447 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Severe local reaction8
RR 0.05 [0, 0.89]1 study · 447 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Non‐severe local reaction10
RR 0.64 [0.52, 0.79]1 study · 447 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Fever14
RR 1.44 [1.01, 2.06]1 study · 447 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness

Comparison between needles with different gauges but with the same length

Population: infants aged approximately 2 to 6 months undergoing vaccination in the anterolateral thigh with a DTwP combination vaccine
CD010720.PUB3 (current) · 11 questions
OutcomeEffectEvidenceStatus / GRADE
Incidence of diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib) (not measured)
no estimate extractedNRNo studies
2a. Adequate immune response (seroprotection) against diphtheria (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 311 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2b. Adequate immune response (seroprotection) against tetanus (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 402 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2c. Adequate immune response (seroprotection) against pertussis (not measured)
no estimate extractedNRNo studies
2d. Adequate immune response (seroprotection) against Haemophilus influenzae type b disease (surrogate outcome)
RR 1.03 [0.96, 1.11]1 study · 414 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Pain: 0 to 10 on MBPS 0 = no pain; 10 = worst possible pain4
no estimate extracted1 study · 320 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness
4a. Procedural crying (during and immediately after the vaccination procedure)
no estimate extracted1 study · 320 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
4b. Persistent inconsolable crying8
RR 1.31 [0.36, 4.8]1 study · 459 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Severe local reaction11
no estimate extracted2 studies · 559 participantsHigh
Non‐severe local reaction13
RR 0.92 [0.73, 1.17]1 study · 459 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Fever
no estimate extracted2 studies · 561 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness

Comparison between needles with different lengths and different gauges

Population: infants aged approximately 2 to 6 months undergoing vaccination in the anterolateral thigh with a DTwP‐Hib vaccine
CD010720.PUB3 (current) · 11 questions
OutcomeEffectEvidenceStatus / GRADE
Incidence of diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib) (not measured)
no estimate extractedNRNo studies
2a. Adequate immune response (seroprotection) against diphtheria (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 309 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2b. Adequate immune response (seroprotection) against tetanus (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 394 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2c. Adequate immune response (seroprotection) against pertussis (not measured)
no estimate extractedNRNo studies
2d. Adequate immune response (seroprotection) against Haemophilus influenzae type b disease (surrogate outcome)
RR 1.06 [0.97, 1.16]1 study · 402 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Pain (not measured)
no estimate extractedNRNo studies
4a. Procedural crying (during and immediately after the vaccination procedure) (not measured)
no estimate extractedNRNo studies
4b. Persistent inconsolable crying4
RR 1.9 [0.35, 10.26]1 study · 458 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Severe local reaction8
RR 0.11 [0.01, 0.83]1 study · 458 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Non‐severe local reaction11
RR 0.69 [0.57, 0.84]1 study · 458 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Fever15
RR 1.14 [0.78, 1.66]1 study · 458 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness

Comparison 1: Comparison between needles with different lengths but with the same gauge

Population: infants aged approximately 2‐6 months undergoing vaccination in the anterolateral thigh with a DTwP‐Hib vaccine
CD010720.PUB2 · 11 questions
OutcomeEffectEvidenceStatus / GRADE
Incidence of diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib) (not measured)
no estimate extractedNRNo studies
2a. Adequate immune response (seroprotection) against diphtheria (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 312 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2b. Adequate immune response (seroprotection) against tetanus (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 390 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2c. Adequate immune response (seroprotection) against pertussis (not measured)
no estimate extractedNRNo studies
2d. Adequate immune response (seroprotection) against Haemophilus influenzae type b disease (surrogate outcome)
RR 1.1 [1.01, 1.2]1 study · 400 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Pain (not measured)
no estimate extractedNRNo studies
4a. Procedural crying (during and immediately after the vaccination procedure) (not measured)
no estimate extractedNRNo studies
4b. Persistent inconsolable crying4
RR 2.49 [0.49, 12.7]1 study · 447 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Severe local reaction8
RR 0.05 [0, 0.89]1 study · 447 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Non‐severe local reaction10
RR 0.64 [0.52, 0.79]1 study · 447 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Fever14
RR 1.44 [1.01, 2.06]1 study · 447 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness

Comparison 2: Comparison between needles with different gauges but with the same length

Population: infants aged approximately 2‐6 months undergoing vaccination in the anterolateral thigh with a DTwP combination vaccine
CD010720.PUB2 · 11 questions
OutcomeEffectEvidenceStatus / GRADE
Incidence of diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib) (not measured)
no estimate extractedNRNo studies
2a. Adequate immune response (seroprotection) against diphtheria (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 311 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2b. Adequate immune response (seroprotection) against tetanus (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 402 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2c. Adequate immune response (seroprotection) against pertussis (not measured)
no estimate extractedNRNo studies
2d. Adequate immune response (seroprotection) against Haemophilus influenzae type b disease (surrogate outcome)
RR 1.03 [0.96, 1.11]1 study · 414 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Pain: 0 to 10 on MBPS 0 = no pain; 10 = worst possible pain4
no estimate extracted1 study · 320 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness
4a. Procedural crying (during and immediately after the vaccination procedure)
no estimate extracted1 study · 320 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
4b. Persistent inconsolable crying8
RR 1.31 [0.36, 4.8]1 study · 459 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Severe local reaction11
no estimate extracted2 studies · 559 participantsHigh
Non‐severe local reaction13
RR 0.92 [0.73, 1.17]1 study · 459 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Fever
no estimate extracted2 studies · 561 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness

Comparison 3: Comparison between needles with different lengths and different gauges

Population: infants aged approximately 2‐6 months undergoing vaccination in the anterolateral thigh with a DTwP‐Hib vaccine.
CD010720.PUB2 · 11 questions
OutcomeEffectEvidenceStatus / GRADE
Incidence of diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib) (not measured)
no estimate extractedNRNo studies
2a. Adequate immune response (seroprotection) against diphtheria (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 309 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2b. Adequate immune response (seroprotection) against tetanus (surrogate outcome)
RR 1 [0.99, 1.01]1 study · 394 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
2c. Adequate immune response (seroprotection) against pertussis (not measured)
no estimate extractedNRNo studies
2d. Adequate immune response (seroprotection) against Haemophilus influenzae type b disease (surrogate outcome)
RR 1.06 [0.97, 1.16]1 study · 402 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Pain (not measured)
no estimate extractedNRNo studies
4a. Procedural crying (during and immediately after the vaccination procedure) (not measured)
no estimate extractedNRNo studies
4b. Persistent inconsolable crying4
RR 1.9 [0.35, 10.26]1 study · 458 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Severe local reaction8
RR 0.11 [0.01, 0.83]1 study · 458 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Non‐severe local reaction11
RR 0.69 [0.57, 0.84]1 study · 458 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness
Fever15
RR 1.14 [0.78, 1.66]1 study · 458 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness