Acetaminophen and Post Circumcision Pain Control
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/11/2016 |
| Start Date: | September 2015 |
| End Date: | December 2016 |
| Contact: | Roya O'Neal, MD |
| Email: | rs3176@columbia.edu |
| Phone: | 212-305-7623 |
Infants do not routinely receive acetaminophen for pain control after circumcision. This
study will determine if acetaminophen is effective at controlling infant pain after
circumcision using nerve block and oral dextrose. Infants will undergo the routine
circumcision procedure , and half will be randomly selected to receive half acetaminophen
immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate,
respiratory rate, oxygen saturation), NIPS (the neonatal infant pain scale), and salivary
cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated
pain scoring system based on the appearance of the infant. A reduction in NIPS for those
infants who receive acetaminophen versus nothing will be our primary outcome to determine if
our study is significant.
study will determine if acetaminophen is effective at controlling infant pain after
circumcision using nerve block and oral dextrose. Infants will undergo the routine
circumcision procedure , and half will be randomly selected to receive half acetaminophen
immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate,
respiratory rate, oxygen saturation), NIPS (the neonatal infant pain scale), and salivary
cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated
pain scoring system based on the appearance of the infant. A reduction in NIPS for those
infants who receive acetaminophen versus nothing will be our primary outcome to determine if
our study is significant.
All subjects and controls will be nil per os (NPO) ONLY 30 minutes post procedure, not
before the procedure. Due to the cortisol collection requirements, infants will remain NPO
30 minutes post the procedure to ensure accurate levels, per manufacturer protocol. All
infants will undergo a standardized circumcision using a modified dorsal penile nerve block
(DPNB), dextrose+pacifier and a Gomco clamp. Before being removed from the circumstraint,
half the infants will receive 15 mg/kg of acetaminophen via a syringe.
Neonates will be monitored at time -15, time 0, 30, 60, 90, 120 and 240 minutes for heart
rate (HR), respiratory rate (RR), and pulse oximetry (Sa02), for pain using standard NIPS,
and at -15 and 30 minutes for salivary cortisol level. Time -15 minutes will be defined as
just prior to placement in restraint, assuming about a 15 interval to the full completion of
the procedure and time 0 as the point just prior to removal from restraint and
administration of acetaminophen. The NIPS and vital signs will be determined by Dr. Kimon
Violaris, a neonatologist trained in obtaining NIPS and the entire procedure will be
recorded.
In addition to usual vital sign assessments, infants will be monitored for pain using NIPS-
neonatal infant pain score, a validated infant pain scoring system based on 6 behavioral
criteria: 1. facial expression 0 (relaxed), 1 (grimace) 2. cry 0 (none) , 1 (whimper) , 2
(vigorous) 3. arms 0 (relaxed/restrained) ,1 (flexed/extended) 4. legs 0
relaxed/restrained),1 (flexed/extended) 5. state of arousal 0 (sleeping),1 (awake).
B. Salivary cortisol levels will be collected using a salivary swab kit provided by the
manufacturer, Salimetrics.
C. Vital signs of HR, RR, pulse ox will be measured.
before the procedure. Due to the cortisol collection requirements, infants will remain NPO
30 minutes post the procedure to ensure accurate levels, per manufacturer protocol. All
infants will undergo a standardized circumcision using a modified dorsal penile nerve block
(DPNB), dextrose+pacifier and a Gomco clamp. Before being removed from the circumstraint,
half the infants will receive 15 mg/kg of acetaminophen via a syringe.
Neonates will be monitored at time -15, time 0, 30, 60, 90, 120 and 240 minutes for heart
rate (HR), respiratory rate (RR), and pulse oximetry (Sa02), for pain using standard NIPS,
and at -15 and 30 minutes for salivary cortisol level. Time -15 minutes will be defined as
just prior to placement in restraint, assuming about a 15 interval to the full completion of
the procedure and time 0 as the point just prior to removal from restraint and
administration of acetaminophen. The NIPS and vital signs will be determined by Dr. Kimon
Violaris, a neonatologist trained in obtaining NIPS and the entire procedure will be
recorded.
In addition to usual vital sign assessments, infants will be monitored for pain using NIPS-
neonatal infant pain score, a validated infant pain scoring system based on 6 behavioral
criteria: 1. facial expression 0 (relaxed), 1 (grimace) 2. cry 0 (none) , 1 (whimper) , 2
(vigorous) 3. arms 0 (relaxed/restrained) ,1 (flexed/extended) 4. legs 0
relaxed/restrained),1 (flexed/extended) 5. state of arousal 0 (sleeping),1 (awake).
B. Salivary cortisol levels will be collected using a salivary swab kit provided by the
manufacturer, Salimetrics.
C. Vital signs of HR, RR, pulse ox will be measured.
Inclusion Criteria:
Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery
who's parents are requesting circumcision. Eligibility includes
1. Apgar score at 5 minutes >7
2. birthweight greater than 2.4 kg
3. Age of at least 10 hours
4. At least one void.
Exclusion Criteria:
1. Newborns of substance abusing mothers.
2. Newborns with any contraindications to routine circumcision, anatomical or
hematologic.
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