Craniosynostosis Repair Clinical Trial
Official title:
The Effect of Gender on the Consumption of Pain Medication in Infants Undergoing Craniosynostosis Repair or Untethering of Cord in ITU
| Verified date | November 2013 |
| Source | Tel-Aviv Sourasky Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
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.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 1 Year |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Tel-Aviv Sourasky Medical Center |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The average amount per kg of analgesic medications in male and female infants 0-1 year old. | The first 24h after surgery | No | |
| Primary | The average reduction in pain severity score after receiving analgesics in male and female infants. | 24h after surgery | No |