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. 2021 Mar 31;2021(3):CD012250. doi: 10.1002/14651858.CD012250.pub2

2. Pain as reported in individual trials.

Study ID Device type Pain outcome parameter Pain during first 24 hours Pain during the first 7 days Pain on device removal Pain during erection
Huo 2015 Crush VAS (mean, SD) Mean score: 1.9 (SD 1.3) with device vs 5.2 (SD 1.7) with surgery; P < 0.01 Not reported Not applicable Not reported
Jin 2015 Crush VAS (mean, SD) Mean intraoperative pain score: 0.8 (SD 0.5) with device vs 2.4 (SD 0.8) with surgery; P < 0.001
Mean 1‐hour postoperative pain scores: 4.0 (SD 0.9) with device vs 5.8 (SD 1.0) with surgery; P < 0.001
Not reported Not applicable Not reported
Kanyago 2013 Crush VAS (median, IQR) Median pain score: 1/10 (IQR 0–4) with device vs 3/10 (IQR 2–5) with surgery; P = 0.01 Pain‐free at 3 days: 69.9% with device vs 62.7% with surgery; RR 1.11, 95% CI 0.87 to 1.43; P = 0.5. All participants in both groups were pain free at 7 days Not reported Not reported
Lagarde 2009 Crush VAS (mean pain score [0–10]) Not reported As‐treated analyses results: mean pain score at postoperative day 3: 9.5 with TK vs 6.1 with FG; P = 0.003 Not applicable Not reported
Li 2010 Crush VAS (mean, SD) Mean intraoperative pain score: 0.21 (SD 0.65) with SR vs 3.72 (SD 1.45) with surgery
Mean pain score at 24 hours: 1.83 (SD 0.86) with SR vs 5.27 (SD 1.74) with surgery
Not reported Not applicable Not reported
Li 2014 Crush VAS (mean, SD) Mean intraoperative pain score: 0.81 (SD 0.81) with for DCSD vs 2.42 (SD 1.15) with surgery; P < 0.05
Mean pain score at 24 hours: 1.84 (SD 1.02) with DCSD vs 4.99 (SD 1.36) with surgery; P < 0.05
Not reported Not applicable Not reported
Lv 2014 Crush VAS (mean, SD) Mean intraoperative pain score: 1.9 (SD 1.3) with DCSD vs 5.8 (SD 2.1) with SR vs 6.2 (2.2) with surgery. Pain scores using DCSD was significantly lower than both SR and surgical circumcision; P < 0.001 Pain scores at 1 week: 2.7 (SD 0.9) with DCSD vs 6.4 (SD 2.0) with SR vs 3.3 (SD 0.8) with surgery; P < 0.001 Not reported for SR. Not applicable for DCSD Not reported
Miao 2015 Crush VAS (mean, SD) Mean intraoperative pain score: 1.37 (SD 0.68) with DCSD vs 1.20 (SD 0.79) with foreskin cerclage vs 3.06 (SD 0.75) with surgery. Pain scores using foreskin cerclage were significantly lower than surgical circumcision; P < 0.05
Mean pain score at 24 hours: 1.85 (SD 0.63) with DCSD vs 3.18 (SD 0.82) with foreskin cerclage vs 1.82 (SD 0.75) with surgery
Not reported Not applicable Not reported
Millard 2013 Crush VAS (mean, SD) Mean pain score: 3.3 (SD 2.7) with device vs 3.3 (SD 2.4) with conventional surgery; P = 0.91 Mean score at 48 hours: 1.8 (SD 1.6) with device vs 2.5 (SD 1.9) with conventional surgery; P = 0.008 Not applicable Not reported
Millard 2014 Crush VAS (mean, SD) Mean pain score: 4.2 (SD 2.7) with device vs 3.1 (SD 2.4) with conventional surgery; P = 0.01 Mean score reported at 48 hours: 0.7 (SD 1.6) with device vs 1.2 (SD 2) with conventional surgery; P = 0.04 Not applicable Not reported
Mutabazi 2012 Ligature VAS (mean, SD) During placement: mean pain levels: 0.8 (SD 1.2) with device vs 2.4 (SD 0.9) with surgery
Mean pain score at 1 hour: 5.6 (SD 1.8) with device vs 3.8 (SD 2.1) with surgery
Mean pain score at 2 hours: 4.1 (SD 1.9) with device vs 2.3 (SD 1.6) with surgery
Mean pain score at 3 hours: 2.8 (SD 1.8) with device vs 1.4 (SD 1.5) with surgery
Mean pain score at 4 hours: 1.9 (SD 1.5) with device vs 0.9 (SD 1.3) with surgery
Mean pain score at 8 hours: 1.1 (SD 1.6) with device vs 0.7 (SD 1.2) with surgery
Mean pain score at 16 hours: 0.3 (SD 0.8) with device vs 0.9 (SD 1.5) with surgery
Statistical difference between groups were not reported
Not reported Mean pain levels were 4.7 (SD 1.9) during device removal vs 1.4 (SD 1.6) 1 hour immediately after removal.
Statistical significance not reported
Mean pain levels during erection at day 3: 2.5 (SD 1.8) with device vs 5.2 (SD 2.2) with surgical methods.
Mean pain score during erection at day 9: 1.9 (SD 1.5) with device.
The pain scores during erection for the surgical group was significant higher compared with the PrePex group (P<0.0001).
Pang 2015 Crush Not reported Not reported Not reported Not applicable Not reported
Ren 2014 Crush Not reported Not reported Not reported Not applicable Not reported
Shenje 2016 Crush VAS (Median, IQR) Median intraoperative pain score: 1 (IQR 0.5–2) with device vs 1 (IQR 0 to 2) with surgery
Median immediate postoperative pain score: 1 (IQR 0.5–2) with device vs 1 (IQR 0–5) with surgery
Not reported Not applicable Not reported
Sokal 2014 Crush VAS (mean, SD) and VAS (median, IQR) Immediately after procedure and 1 hour: Kenya: pain scores: 0.2 with device vs 1.2 with surgery (P < 0.001), but was the same 1 hour after surgery (combined mean 3.8 [SD 1.8]). Zambia: pain scores: 0.6 with device vs 0.2 with surgery (P = 0.046), but were similar 1 hour after surgery (combined mean 3.4 [SD 1.9]) At 2 days: similar pain scores in both groups with median VAS scores of 1.0 Not reported SR had worse pain during erections: 3.5 (SD 1.9) with SR vs 2.3 (SD 1.7) with surgery (P < 0.001). This required early removal in 2 cases
Tshimanga 2016 Ligature VAS (categories 0, 2, 4, 6, 8) with percentages of participants experiencing pain at these levels Periprocedurally: all participants in device groups had VAS score of 0, while over 90% in surgical group had a VAS score 4–6. After procedure: device group had VAS score of 0 up to 3 hours while surgical group had VAS score 0–2. No statistical differences were reported 111/160 (69%) participants experienced pain (VAS 0–2) at end of the first week with the device vs 14/80 (17.5%) participants with surgery Transient pain (VAS 2–6) reported in 93.6% of device group. Pain after removal reported in 66% Pain during erection (VAS 2–4): 81/160 (51%) participants with device vs 57/80 (71%) participants with surgery
Wang 2014 Crush Categorically: minor (no/slight pain), moderate (tolerable pain) and severe (intolerable pain requiring medication or intervention with acetaminophen) on days 1, 3, 7 and 14; with numbers per category 53 minor pain, 4 moderate pain and 1 severe pain with devices vs 54 minor pain, 6 moderate pain and 0 severe pain Day 3
Wang 2017 Crush VAS (the units of measurement, i.e. mean/median, were not specified) Pain scores: 6 hours after operation: 5.13 (SD 1.14) with disposable stitching device vs 7.16 (SD 1.23) with surgery; P < 0.0001
12 hours after operation: 3.16 (SD 1.13) with disposable stitching device vs 5.33 (SD 1.25) with surgery; P < 0.0001
24 hours after operation: 1.85 (SD 1.14) with disposable stitching device vs 3.58 (SD 1.26) with surgery; P < 0.0001
Postoperative VAS score improvements in the device group were significantly higher than those of the surgery group at the time points specified
Not reported Not applicable Not reported

CI: confidence interval; DCSD: disposable circumcision disposable device; FG: forceps guided; IQR: interquartile range; n: number; RR: risk ratio; SD: standard deviation; SR: Shang Ring; TK: Tara KLamp; VAS: visual analog scale