Background: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. It was thought that the newborn baby does not experience pain because of incompletely developed nervous system. However, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional. OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline. STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial. POPULATION: We will include full term neonates, who will be recruited from the inpatient nursery at Makassed General Hospital over a 1-year period. OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured using the Neonatal Infant Pain Score. Secondary outcome is to assess effect of 30% glucose oh physiologic parameters
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
60
Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision
Male neonates will receive 2 ml of sterile water two minutes prior to circumcision
Makassed General Hospital
Beirut, Lebanon
RECRUITINGPain score
Pain response will be assessed utilizing the Neonatal Infant Pain Scale. The total pain score ranges from 0 to 10. Scores less than or equal to 3 indicate no pain while scores greater than 3 indicate pain.
Time frame: Pain will be assessed 1 minute before the procedure and during the procedure
Heart rate
Heart rate (beats per minute) will be recorded
Time frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
Respiratory rate
Respiratory rate (breaths per minute) will be recorded
Time frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
Oxygen saturation
Oxygen saturation (in percent) will be recorded
Time frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
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