Phase 2
Completed N=64
A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children
Hematologic Diseases · Neoplasms
Source: ClinicalTrials.gov NCT00213239 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion — 0.96; 0.28; 1.50; 0.52 micrograms/kg
Summary
This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion |
0.96; 0.28; 1.50; 0.52 | — |
| SECONDARY Incidence of Adverse Events. |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of a hemato-oncological disorder
- Scheduled to undergo a lumbar puncture
- Aged 4-11 years
- Male or female
- Unpremedicated
- Willing and able to provide informed consent (or informed consent by parents)
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 (NCT00213239). 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. Informational only — not medical advice.