Table 2.
Randomized controlled trials for non-pharmacological methods of pain relief in infants.
| First Author, Year | Population | Intervention | Other Intervention | Primary Outcome | p-Value | |
|---|---|---|---|---|---|---|
| Intervention | Control | |||||
| Shabani, 2016 [9] | Preterm (n = 20) |
MT | N/A | Facial pain expressions M (SD): MT: 0.4 (0.1) |
Control: 2.1 (0.4) | 0.001 |
| Seo, 2016 [10] | Term (n = 56) |
SSC | N/A | PIPP M ± SD: SSC: 4.1 ± 2.3 |
Control: 6.3 ± 3.5 | 0.01 |
| Freire, 2008 [11] | Preterm (n = 95) |
SSC | Glucose | HR M ± SD: SSC: 5.1 ± 3.9 bpm Glucose: 9.9 ± 6.1 bpm |
Control: 10.8 ± 6.5 bpm | SSC vs. glucose: 0.0001 SSC vs. control: 0.0001 |
| Olsson, 2016 [12] | Preterm (n = 10) |
SSC | N/A | PIPP M: 5.7 | Control: 5.0 | >0.05 (NS) |
| Efendi, 2018 [13] | Preterm (n = 30) |
Pacifier and swaddling | N/A | Increase in pain score: Swaddle: 5.9 ± 2.2 to 6.1 ± 2.0 |
Control: 5.4 ± 1.8 to 7.7 ± 2.7 | Swaddling: NS Control: 0.003 |
| Erkut, 2017 [14] | Term (n = 74) |
Swaddle | N/A | NIPS M ± SD: Swaddle: 1.6 ± 0.8 |
Control: 3.3 ± 1.5 | 0.01 |
| Ho, 2016 [15] | Preterm (n = 54) |
Swaddle | N/A | PIPP M ± SD: Swaddle: 7.0 ± 2.7 |
Control: 14.7 ± 2.9 | <0.001 |
| Axelin, 2006 [16] | Preterm (n = 20) |
FT | N/A | NIPS Median (IQR): FT: 3 (2–6) |
Control: 5 (2–7) | <0.001 |
| Arikan, 2008 [17] | Preterm/term (n = 175) |
Massage | Sucrose herbal tea, hydrolyzed formula |
Crying time after procedure M ± SD: Massage: 4.4 ± 1.8 s Sucrose: 3.9 ± 1.5 s Tea: 3.2 ± 1.2 s Formula: 2.7 ± 1.1 s |
Control: 5.3 ± 1.76 s | Comparing before and after procedure: p < 0.001 for all but control (p > 0.05) |
| Chik, 2017 [18] | Preterm/term (n = 80) |
Massage | N/A | PIPP M (SD): Massage: 6 (3.3) |
Control: 12 (4.3) | <0.001 |
| Jain, 2006 [19] | Preterm (n = 23) |
Massage | N/A | NIPS M (SD): Massage: 1.5 (0.9) |
Control: 3.5 (1.6) | <0.001 |
| Zhu, 2015 [20] | Term (n = 250) |
MT | BF | NIPS M (SD): MT: not significant MT + BF: not significant BF: 3.1 (1.9) |
Control: 6.4 (0.2) | BF vs. control: <0.001 |
| Shah, 2017 [21] | Preterm/term (n = 35) | MT | Sucrose | PIPP median (IQR): MT: 6 (3–11) MT + sucrose: 3 (0–4) |
Sucrose: 5 (3–10) | MT vs. sucrose: >0.05 MT + sucrose vs. sucrose: <0.001 MT + sucrose vs. MT: <0.001 |
| Zurita-Cruz, 2017 [22] | Term (n = 144) |
BF | MS | Crying time Median (IQR): BF: 19 (0–136) MS: 41.5 (0–184) |
Control: 41 (0–161) | BF vs. control: 0.007 Control vs. MS: >0.05 |
| Erkul, 2017 [23] | Term (n = 100) |
BF | N/A | NIPS M ± SD: BF: 1.9 ± 2.2 |
Control: 6.8 ± 0.7 | <0.05 |
| Simonse, 2012 [24] | BF | Bottle fed, sucrose |
PIPP M (95%CI): BF: 7.0 (5.3–8.7) Bottle fed: 5.4 (3.7–7.1) |
Sucrose: 5.3 (3.6–6.9) | BF vs. bottle fed: >0.05 BF vs. sucrose: >0.05 |
|
| Baudesson, 2017 [25] | Preterm (n = 33) |
MO | N/A | PIPP M (SD): MO: 7.3 (3.0) |
Control: 10 (3.5) | 0.03 |
| Mitchell, 2016 [26] | Term (n = 162) |
NESAP | Sucrose | PIPP M ± SD: NESAP: 5.0 ± 4.0 Sucrose: 4.0 ± 1.8 NESAP + sucrose: 3.6 ± 1.2 |
Control: 4.9 ± 4.0 | <0.01 |
| Chen, 2017 [27] | Preterm/term (n = 30) |
MA | N/A | PIPP M ± SD: MA: 5.9 ± 3.7 |
Control: 8.3 ± 4.7 | 0.04 |
| Abbasoglu, 2015 [28] | Preterm (n = 32) |
Acupressure | N/A | PIPP M ± SD: Acupressure: 9.1 ± 2.0 |
Control: 9.6 ± 1.7 | 0.5 |
| Lima, 2017 [29] | Term (n = 78) |
NNS | Glucose | NIPS M ± SD: NNS: 33.9 ± 17.6 |
Glucose: 10.9 ± 11.3 | <0.001 |
| Gouin, 2018 [30] | Term (n = 245) |
Sucrose | N/A | NIPS M ± SD: Sucrose: 2.3 ± 0.5 |
Control: 1.6 ± 0.5 | 0.6 |
| Collados-Gómez, 2018 [31] | Preterm (n = 66) |
Sucrose | EBM | PIPP Median (IQR): Sucrose: 6 (4–8) |
EBM: 7 (4–9) | 0.28 |
M: mean, SD: standard deviation, IQR: interquartile range, NS: not significant, HR: heart rate, SSC: skin-to-skin care, FT: facilitated tuck, MT: musical therapy, BF: breast feeding, MO: milk odor, NS: non-significant, NNS: non-nutritive sucking, NESAP: non-invasive electrical stimulation at acupuncture points, N/A: not/applicable, MS: milk substitute, EBM: expressed breastmilk, PIPP: Premature Infant Pain Profile, NIPS: Neonatal Infant Pain Scale, bpm: beats per minute.