Trial Outcomes & Findings for A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children (NCT NCT00213239)

NCT ID: NCT00213239

Last Updated: 2019-12-02

Results Overview

Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: Movement measured at the time of lumbar puncture needle insertion.
• Results posted on: 2019-12-02

Participant Flow

Participant milestones

Measure	Propofol 4 mg/kg Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.	Propofol 2mg/kg Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
Overall Study STARTED	32	32
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children

Baseline characteristics by cohort

Measure	Propofol 4mg/kg n=32 Participants Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.	Propofol 2mg/kg n=32 Participants Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.	Total n=64 Participants Total of all reporting groups
Age, Continuous	5.6 years STANDARD_DEVIATION 2.6 • n=93 Participants	5.2 years STANDARD_DEVIATION 2.1 • n=4 Participants	5.3 years STANDARD_DEVIATION 2.4 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	13 Participants n=4 Participants	23 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	19 Participants n=4 Participants	41 Participants n=27 Participants

PRIMARY outcome

Timeframe: Movement measured at the time of lumbar puncture needle insertion.

Population: Minimum effective dose of remifentanil to prevent movement during lumbar puncture insertion

Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion

Outcome measures

Measure	2.0 mg/kg Propofol n=32 Participants Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.	4.0 mg/kg Propofol n=32 Participants Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion Minimum effective dose	0.96 micrograms/kg Standard Deviation 0.23	0.28 micrograms/kg Standard Deviation 0.22
Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion ED98	1.50 micrograms/kg Standard Deviation 1.0	0.52 micrograms/kg Standard Deviation 1.06

SECONDARY outcome

Timeframe: Followed for the length of the procedure.

Outcome measures

Measure	2.0 mg/kg Propofol n=32 Participants Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.	4.0 mg/kg Propofol n=32 Participants Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
Incidence of Adverse Events. Bradycardia	0 Participants	0 Participants
Incidence of Adverse Events. Hypotension	0 Participants	0 Participants

Adverse Events

Propofol 4 mg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol 2mg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Propofol 4 mg/kg n=32 participants at risk Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.	Propofol 2mg/kg n=32 participants at risk Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
General disorders Bradycardia	0.00% 0/32 • Adverse events were recorded from administration of study drugs until discharge from recovery room.	0.00% 0/32 • Adverse events were recorded from administration of study drugs until discharge from recovery room.
General disorders Hypotension	0.00% 0/32 • Adverse events were recorded from administration of study drugs until discharge from recovery room.	0.00% 0/32 • Adverse events were recorded from administration of study drugs until discharge from recovery room.

Additional Information

Dr. Jason Hayes

The Hospital for Sick Children, Department of Anesthesia and Pain Medicine

Phone: 416-813-7654

Email: jason.hayes@sickkids.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place