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

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ClinicalTrials.gov Identifier: NCT01996163
Recruitment Status : Unknown
Verified November 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

November 21, 2013
November 27, 2013
November 27, 2013
December 2013
December 2014   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
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The Effect of Gender on the Consumption of Pain Medication in Infants Undergoing Craniosynostosis Repair or Untethering of Cord in ITU
The Effect of Gender on the Consumption of Pain Medication in Infants Undergoing Craniosynostosis Repair or Untethering of Cord in ITU

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample
All infants 0-1 year old, admitted to PICU after craniosynostosis repair or untethering of cord.
  • Craniosynostosis Repair
  • Untethering of Cord
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  • Male
  • Female
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
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December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Contraindication to analgesic medication
  2. Infants with neurologic deficits that may hinder the assessment of pain severity such as facial nerve palsy and limb paralysis.
  3. Ventilated infants.
Sexes Eligible for Study: All
up to 1 Year   (Child)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01996163
TASMC-13-FS-0561-13-CTIL
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Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
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Tel-Aviv Sourasky Medical Center
November 2013