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Clinical Trials/NCT01996163
NCT01996163
Unknown
Not Applicable

The Effect of Gender on the Consumption of Pain Medication in Infants Undergoing Craniosynostosis Repair or Untethering of Cord in ITU

Tel-Aviv Sourasky Medical Center0 sites40 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Craniosynostosis Repair
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
40
Primary Endpoint
The average amount per kg of analgesic medications in male and female infants 0-1 year old.
Last Updated
12 years ago

Overview

Brief Summary

Postoperative pain is a major concern in routine management of children admitted to pediatric intensive care treatment. There are significant negative physiological and psychological ramifications of postoperative pain such as impairment of cardiac function due to tachycardia, restlessness in an intubated patient requiring increase dosage of sedative and paralytic drugs and reduced patient cooperation in the healing process.

The main body of evidence dealing with gender differences in pain perception and treatment stems from studies in the adult and adolescent population as the gonadal hormones have a central role in the way one experiences pain The hypothesis of this study is that there is a difference in the perception of pain, the amount of analgesia used and the response to pain medication between male and female infants undergoing craniosynostosis repair or untethering of cord.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 2014
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All infants 0-1 year old, admitted to PICU after craniosynostosis repair or untethering of cord.

Exclusion Criteria

  • Contraindication to analgesic medication
  • Infants with neurologic deficits that may hinder the assessment of pain severity such as facial nerve palsy and limb paralysis.
  • Ventilated infants.

Outcomes

Primary Outcomes

The average amount per kg of analgesic medications in male and female infants 0-1 year old.

Time Frame: The first 24h after surgery

The average reduction in pain severity score after receiving analgesics in male and female infants.

Time Frame: 24h after surgery

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