An observational study in Craniosynostoses and Pain, Postoperative, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 3 Months to 2 Years. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Postoperative analgesia after corrective surgery of paediatric craniosynostosis is crucial in term of short and long-term outcomes. The objective of this observational case- control study was to evaluate the effectiveness of an analgesic technique based on the scalp block versus traditional pharmacological approach.
Several studies on craniosynostosis and the correlated risk factors have been published, the majority of them focusing on the perioperative management of blood losses and avoidance of haemorrhagic shock. Other issues related to anaesthetic management of the surgical correction of craniosynostosis are metabolic and electrolyte disturbances.
Even if craniosynostosis surgery is an invasive procedure, there is a current misconception that it would be associated with minimal pain, despite the extensive exhibition of the skull and periostea dissection. The Literature about the assessment and management of postoperative pain in this particular surgical setting is scarce. Assessment of pain in infants is challenging, and often relies on clinical observation. To date, there are no evaluative and therapeutic parameters globally accredited in this category of patients. The scalp nerve block (SNB) is a regional anaesthetic technique, performed since several years in children undergoing a variety of procedures, from neurosurgery to eye-nose-throat surgery.SNB has been proposed as a complement to the routine craniosynostosis anaesthetic protocol, and should be associated to a reduced need for opioids.
Thirteen patients, aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis were subjected to SNB (Group SB) with Levobupivacaine 0.125% (total dose 2 mg/kg), performed before awakening, in combination with intraoperative intravenous acetaminophen (15 mg/kg if body weight >10Kg, 7 mg/kg if body weight \< 10 kg). The SNB procedure was performed using the modified Pinosky technique, with levobupivacaine 0,125%(10). A targeted infiltration of 0,75-2ml of local anaesthetic (LA) solution was done at multiple sites with a 23G needle.
This Group of patients were compared with another group of 13 patients, derived from our database, and treated with the traditional pharmacological approach given intraoperatively (intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg).
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 26 is below the median of 43 across 26 observational studies indexed under Craniosynostoses.
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patients with aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis
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Exclusion Criteria:
Scalp block performed with Levobupivacaine 0.125% (total dose 2 mg/kg) in combination with intraoperative intravenous acetaminophen (15 mg/kg if body weight \>10Kg, 7 mg/kg if body weight \< 10 kg).
Other: scalp block
intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg
intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg)
Also known as: intravenous pharmacological approach
pain intensity
Objective Pain Score incorporates four pain behaviors (crying, movement, agitation, and verbalization) and was evaluated at following times: * 30 minutes after extubation (T0) * 2 hours after extubation (T1) * 4 hours after extubation (T2) * 8 hours after extubation (T3) * at discharge from Pediatric Intensive Care Unit (T4). * at in the Neurosurgical ward OPS was assessed every eight hours, until the fifth day of hospitalization.
Time frame: OPS was assessed until the fifth day of hospitalization.
resumption of oral nutrition
evaluation of post-operative feeding recovery time
Time frame: first postoperative day
Plan to share: No
Ran from Jan 2016 to primary completion in Jun 2016, 5 months.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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