ClinicalTrials.Veeva

Menu

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

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Untethering of Cord
Craniosynostosis Repair

Study type

Observational

Funder types

Other

Identifiers

NCT01996163
TASMC-13-FS-0561-13-CTIL

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Male
Female

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems