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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01996163
Enrollment
40
Registered
2013-11-27
Start date
2013-12-31
Completion date
Unknown
Last updated
2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniosynostosis Repair, Untethering of Cord

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.

Interventions

None listed

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The average amount per kg of analgesic medications in male and female infants 0-1 year old.The first 24h after surgery
The average reduction in pain severity score after receiving analgesics in male and female infants.24h after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026