Al Qahtani 2014.
Methods | RCT Painful intervention: circumcision Study location: Day Care Surgery Department of Maternity and Children Hospital, Dammam City, Kingdom of Saudi Arabia Study period: January 2011 and April 2011 |
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Participants | 90 full‐term newborn males who underwent circumcision GA of 38 weeks or beyond, 5 min Apgar score of 8 or higher, PNA of 12 h or older and birthweight > 2500 g, and to be free from jaundice, anomalies of the penis, and analgesia or sedation in the previous 48 h |
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Interventions | 2 mL oral sucrose (24% w/v) given through a dropper onto the tongue 2 min before the procedure (n = 30) EMLA cream: applied to the shaft of the penis with an occlusive dressing 1 h before the procedure (n = 30) Combination of EMLA cream + oral sucrose (n = 30): 1 g EMLA cream applied to the shaft of the penis with an occlusive dressing 1 h before the procedure + 2 mL oral sucrose (24% w/v) given through a dropper onto the tongue 2 min before the procedure |
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Outcomes | N‐PASS used to assess the severity of pain and neonatal response to pain, 5 min before, during and 5 min after the circumcision for all newborns. The scale measures both physiologic responses (HR, respiratory rate, blood pressure and oxygen saturation) and behavioural responses (crying irritability, behaviour state, facial expression and extremities tone) to pain | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided |
Allocation concealment (selection bias) | Low risk | The sample was divided randomly into 3 groups. The envelope was opened to classify the neonate randomly to 1 of the groups in order to carry out the appropriate action |
Blinding (performance bias and detection bias) All outcomes | High risk | Staff were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Video imaging of the neonate 5 min before, during and until 10 min after the procedure showed the newborn reaction to pain and recorded the duration of crying. The videotapes were reviewed by an individual who was unaware of the infant’s treatment group, however, since the sucrose was applied 2 min before the procedure, it was probably possible to tell from the tapes which babies received sucrose |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data reported for all 90 infants |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available to us so we could not judge whether there were any deviations from it |
Other bias | Low risk | Appears free of other bias |