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Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children

T

The Hospital for Sick Children

Status and phase

Completed
Phase 3

Conditions

Spinal Puncture

Treatments

Drug: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Drug: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg

Study type

Interventional

Funder types

Other

Identifiers

NCT00405522
1000009427

Details and patient eligibility

About

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.

Full description

Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Enrollment

34 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups

Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Experimental group
Treatment:
Drug: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Experimental group
Treatment:
Drug: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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