Phase 3
N=34
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children
Spinal Puncture
Bottom Line
View on ClinicalTrials.gov: NCT00405522 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Duration of Apnea — 110; 73 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg (Drug); Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- The Hospital for Sick Children
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Apnea |
110; 73 | — |
| PRIMARY Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement). |
10; 23 | — |
| SECONDARY Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter. |
0; 0 | — |
Summary
The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of a hemato-oncological disorder
- Scheduled to undergo a lumbar puncture
- Aged 3-12 years
- Unpremedicated
Exclusion Criteria
- children who are known or suspected to be difficult to ventilate by face mask
- children who are deemed medically unfit to receive either of the two study medications
- children who are obese (weight for height > 95th percentile)
- children who do not have an indwelling intravenous line
Data sourced from ClinicalTrials.gov (NCT00405522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.