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Status unknownNCT01996163Updated Nov 27, 2013

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

An observational study in Craniosynostosis Repair and Untethering of Cord, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2013-11-27.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
40
Ages
Up to 1 Year
Sex
All
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Study 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.

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Conditions studied

  • Craniosynostosis Repair
  • Untethering of Cord

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In context

Craniosynostoses

51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.

This study's planned enrollment of 40 is close to the median of 43 across 26 observational studies indexed under Craniosynostoses.

Browse Craniosynostoses studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Male
  • Female
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What researchers measure

Primary outcomes

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

    Time frame: The first 24h after surgery

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

    Time frame: 24h after surgery

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01996163
Responsible party
Sponsor
First posted
Nov 27, 2013
Start date
Dec 2013
Primary completion
Dec 2014 (estimated)
Last update
Nov 27, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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