Clinical trial · Interventional
A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children
The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study
NCT00213239CI-TRIAL-00042008completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Diseases | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remifentanil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Propofol 4 mg/kg group
- description
- First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)
- interventionNames
- Drug: Remifentanil
- type
- EXPERIMENTAL
- label
- Propofol 2 mg/kg group
- description
- First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)
- interventionNames
- Drug: Remifentanil
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 11 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTHayes JA, Lopez AV, Pehora CM, Robertson JM, Abla O, Crawford MW. Coadministration of propofol and remifentanil for lumbar puncture in children: dose-response and an evaluation of two dose combinations. Anesthesiology. 2008 Oct;109(4):613-8. doi: 10.1097/ALN.0b013e31818629f3. PMID 18813039