Circumcision, Pain
Conditions
Keywords
Infant pain, Acetaminophen, Circumcision
Brief summary
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), the neonatal infant pain scale (NIPS), 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 the primary outcome to determine if the study is significant.
Detailed description
Male circumcision is a common surgical procedure performed in the newborn period. The American Academy of Pediatrics Task Force on Circumcision recently published an update on circumcision policy stating the benefits of male circumcision outweigh the risks. Given this update, the investigators anticipate a percentage of families who were previously undecided about circumcision will choose to have their newborn circumcised. A common concern for both parents and physicians is effective pain control. For intra-operative pain control, dorsal penile nerve block (DPNB) has been found to be the most effective when compared to EMLA (lidocaine-prilocaine) or placebo. Acetaminophen is a relatively safe, easy to administer analgesic. Prior studies have suggested that acetaminophen could be helpful in postoperative comfort. However, studies examining the effectiveness of acetaminophen for postoperative pain control in infants who received DPNB are lacking. In addition, prior studies have been incomplete in the assessment of neonatal pain.
Interventions
DRUGAcetaminophen
Infants will receive 15 mg/kg of acetaminophen.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
10 Hours to 36 Hours
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Infant Pain Scale (NIPS) | Baseline and 4 hours | The Neonatal Infant Pain Scale (NIPS) is a behavioral scale and can be utilized with both full-term and pre-term infants. The tool uses the behaviors that nurses have described as being indicative of infant pain or distress. It is composed of six (6) indicators: facial expression, cry, breathing patterns, arms, legs and state of arousal. Each behavioral indicator is scored with 0 or 1 except cry, which has three possible descriptors therefore, being scored with a 0, 1 or 2. Infants are observed for one minute in order to fully assess each indicator. Total pain scores range from 0-7, with a score of 0-2 indicating mild to no pain and no suggested intervention (better outcome) to a score \>4 indicating severe pain, suggesting non-pharmacological and/or pharmacological interventions may be needed. |
Secondary
| Measure | Time frame |
|---|---|
| Heart Rate | Baseline and 4 hours |
| Change in Salivary Cortisol Rise | Baseline and 4 hours |
| Respiratory Rate | Baseline and 4 hours |
| Pulse Oximetry | Baseline 4 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. | 6 |
| Control Arm Includes subjects who received routine care post circumcision. | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Neonatal Infant Pain Scale (NIPS)
The Neonatal Infant Pain Scale (NIPS) is a behavioral scale and can be utilized with both full-term and pre-term infants. The tool uses the behaviors that nurses have described as being indicative of infant pain or distress. It is composed of six (6) indicators: facial expression, cry, breathing patterns, arms, legs and state of arousal. Each behavioral indicator is scored with 0 or 1 except cry, which has three possible descriptors therefore, being scored with a 0, 1 or 2. Infants are observed for one minute in order to fully assess each indicator. Total pain scores range from 0-7, with a score of 0-2 indicating mild to no pain and no suggested intervention (better outcome) to a score \>4 indicating severe pain, suggesting non-pharmacological and/or pharmacological interventions may be needed.
Time frame: Baseline and 4 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acetaminophen Arm | Neonatal Infant Pain Scale (NIPS) | Baseline | 2.5 score on a scale |
| Acetaminophen Arm | Neonatal Infant Pain Scale (NIPS) | 4 Hours post-circumcision | 1.0 score on a scale |
| Non-treatment Arm | Neonatal Infant Pain Scale (NIPS) | Baseline | 3.2 score on a scale |
| Non-treatment Arm | Neonatal Infant Pain Scale (NIPS) | 4 Hours post-circumcision | 1.4 score on a scale |
Secondary
Change in Salivary Cortisol Rise
Time frame: Baseline and 4 hours
Population: Only subjects who were able to provide saliva were incorporated into the data analysis. One subject in the acetaminophen arm could not provide a saliva sample for analysis, and 2 subjects in the control arm could not provide saliva samples for analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acetaminophen Arm | Change in Salivary Cortisol Rise | Baseline | 0.389 nmol/L |
| Acetaminophen Arm | Change in Salivary Cortisol Rise | 30 minutes post-circumcision | 1.085 nmol/L |
| Non-treatment Arm | Change in Salivary Cortisol Rise | Baseline | 0.427 nmol/L |
| Non-treatment Arm | Change in Salivary Cortisol Rise | 30 minutes post-circumcision | 0.811 nmol/L |
Secondary
Heart Rate
Time frame: Baseline and 4 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acetaminophen Arm | Heart Rate | 4 Hours post-circumcision | 125 Beats per minute |
| Acetaminophen Arm | Heart Rate | Baseline | 138.7 Beats per minute |
| Non-treatment Arm | Heart Rate | Baseline | 128.8 Beats per minute |
| Non-treatment Arm | Heart Rate | 4 Hours post-circumcision | 124.8 Beats per minute |
Secondary
Pulse Oximetry
Time frame: Baseline 4 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acetaminophen Arm | Pulse Oximetry | Baseline | 98.8 percentage of oxygen saturation |
| Acetaminophen Arm | Pulse Oximetry | 4 Hours post-circumcision | 97.5 percentage of oxygen saturation |
| Non-treatment Arm | Pulse Oximetry | Baseline | 98.2 percentage of oxygen saturation |
| Non-treatment Arm | Pulse Oximetry | 4 Hours post-circumcision | 98.4 percentage of oxygen saturation |
Secondary
Respiratory Rate
Time frame: Baseline and 4 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acetaminophen Arm | Respiratory Rate | Baseline | 59.7 breaths per minute |
| Acetaminophen Arm | Respiratory Rate | 4 Hours post-circumcision | 42 breaths per minute |
| Non-treatment Arm | Respiratory Rate | Baseline | 45 breaths per minute |
| Non-treatment Arm | Respiratory Rate | 4 Hours post-circumcision | 43.6 breaths per minute |