COMPARISON OF EMLA CREAM, WITH AND WITHOUT PARACETAMOL WITH PENILE RING BLOCK FOR CIRCUMCISION PAIN RELIEF IN NEONATES.
Abstract
Background
Various methods are available for circumcision pain relief. However, no single method
has been shown to completely eliminate the pain response to circumcision. Eutectic Mixture of
Local Anaesthetics cream and paracetamol have independently been shown to offer some pain
relief for circumcision. In this study, the effectiveness of analgesia for circumcision provided by
the addition of oral paracetamol at a loading dose of 20mg/kg to EMLA cream was compared
with EMLA cream alone and Penile ring block.
Study Design
This study was a prospective, randomized trial. Approval was obtained from the
University of Benin Teaching Hospital Research and Ethics committee. Eighty four ASA I or II
male neonates scheduled for circumcision were randomized into three groups after written
informed consents were obtained from the parents/guardians . Group I received 1ml of 1% plain
Lignocaine penile ring block, Group II received 1gm of EMLA cream and Group III received
1gm of EMLA cream and 20mg/kg oral paracetamol. The preoperative vital signs (pulse and
respiratory rates) were obtained and recorded.
Intra and post operative pain was assessed at skin incision and at five minute intervals
afterwards using the Neonatal Infant Pain Scale, where scores of 0-2 indicated nil to mild pain,
3-4 mild to moderate pain and > 4, severe pain. Heart rates and respiratory rates were also used
to assess pain. These formed the primary outcomes for the study.
The data obtained were analyzed using the statistical package for social sciences
(SPSS) 16.0 software (Chicago Illinois, USA). All Parametric data were analyzed with one way
ANOVA. Non-parametric data were analyzed with chi square or Fisher exact tests as applicable.
Probability values < 0.05 were considered significant.
Results
There were no significant differences between the groups with regards to body
weight, ASA scores, baseline vital signs and cadre of Surgeon ( p < 0.05 ). Neonatal Infant Pain
Scale scores were comparable between the EMLA and Paracetamol group with the Ring block
group, while EMLA alone had the highest score ( p = 0.003; 0.0004; 0.0001 and 0.0001
respectively at skin incision and 10,15 and 20 minutes after ). This trend was similar in the heart
rates (P= 0.013; 0.0002 and 0.0002 respectively at skin incision, 10 and 20 minutes later). The
respiratory rates were also lowest in the EMLA and paracetamol groups.
The Surgeons were more satisfied with the EMLA and paracetamol and ring block groups than
with EMLA alone. Side effects were minor and included Erythema, 3(11.5%) in the EMLA
alone group, 2(8%) in EMLA plus paracetamol group and haematoma, 3(10.7%) in the penile
block group.
Conclusion
The addition of a loading dose of 20mg/kg of paracetamol to EMLA cream ,
provided similar analgesia compared with Ring block, with both better than EMLA cream alone
for circumcision pain relief.