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Timing for maximum anesthetic effect of topical cream during early infant male circumcision (EIMC) in Rakai, Uganda

Title
Timing for maximum anesthetic effect of topical cream during early infant male circumcision (EIMC) in Rakai, Uganda
Presenter
Stephen Kiboneka
Authors
S. Kiboneka * (1), A. Anok (1), E. Kankaka (1), R. Nakabuye (1), S. Odiya (1), J. Magembe (1), R. Nazziwa (1), C. Ddamulira (1), A. Mukooki (1), J. Kagaya (1), S. Watya (1), P.S. Li (2), R.K. Lee (2), R.H. Gray (3), G. Kigozi (1)
Institutions
(1) Rakai Health Sciences Program, Research, Kalisizo, Uganda, (2) Weill Cornell Medical College, Urology, New York, United States, (3) Johns Hopkins Bloomberg School of Public Health, Epidemiology, Baltimore, United States

BACKGROUND: Male circumcision reduces male HIV acquisition by up to 60%. Early Infant Male Circumcision (EIMC) presents advantages, including faster wound healing, lower cost, and no risk of early sex resumption. Data from recent studies shows that device-based circumcision (ShangRing and Mogen Clamp) is safe in infants aged 0-60 days. However, success of future infant circumcision scale-up programs in sub-Saharan Africa depends on adequate pain control during the procedure. We assessed the optimal timing for application of topical anesthesia for device-based circumcision procedure.
METHODS: 200 infants aged 0-60 days were enrolled in an EIMC trial comparing the Mogen clamp and ShangRing devices at 4 facilities in south-central Uganda. Topical anesthetic
(EMLA cream.) was applied on the entire penile shaft. The anesthetic effect was assessed every 5 minutes, starting at 10 minutes post-application until 60 minutes, the recommended time to start circumcision. Pain was tested at the tip of the foreskin using the Neonatal Infant Pain Scale (NIPS) to assess responses. Mean (SD) and median (IQR) NIPS scores at each time interval were used to determine the time range of maximum anesthesia.
RESULTS: The median NIPS score dropped to zero between 25 to 55 minutes, with the narrowest IQR occurring between 35 and 45 minutes after applying topical cream. The effect started diminishing after 45 minutes. A similar trend was observed for the mean scores (Table 1).

Table 1.0: Table showing the NIPS scores at the different time intervals. (N=200).
Time in minutes1015202530354045505560
Median (IQR)3.0(4.0)2.0(5.0)1.0(4.0)0.0(2.0)0.0(2.0)0.0(1.0)0.0(1.0)0.0(1.0)0.0(2.0)0.0(2.0)1.0(2.0)
Mean (SD)3.3(2.3)2.7(2.4)1.8(2.2)1.2(1.7)1(1.6)0.7(1.3)0.8(1.3)0.8(1.4)1(1.5)1.3(1.7)1.6(1.9)

CONCLUSIONS: The optimal timing for maximum topical analgesia occurred 35 to 45 minutes after application which is less than the recommended 60 minute waiting time. A shorter waiting time may be efficient for mass device-based circumcision.

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