Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation

Children's Hospitals and Clinics of Minnesota

Status: Terminated

Conditions: Pain

Treatments: Drug: Lidocaine; Drug: Normal Saline; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02512783

1302-019

Details and patient eligibility

About

This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

Full description

Propofol is a short-acting, intravenously administered anesthetic. It has become a popular choice for procedural sedation in both children and adults. Despite its many advantages, Propofol is associated with a burning sensation during injection. Propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. Lidocaine is often used in an attempt to reduce Propofol injection pain, but neither its delivery mode nor concentration has been standardized.

The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the FLACC scale.

Enrollment: 171 patients

Sex: All

Ages: 2 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 2 months to 17 years
• patient already scheduled for procedural sedation with propofol
• sedation procedure to be performed by a sedationist from Children's Respiratory and Critical Care Specialists

Exclusion criteria

• patients who are not receiving deep sedation with propofol
• patients with allergy or other contraindication to lidocaine administration
• patients with central venous catheters as propofol does not burn when given centrally
• patients being premedicated with an analgesic other than nitrous oxide or 1% lidocaine
• patients weighing less than 5 kg to prevent any risk of inadvertent lidocaine overdose.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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171 participants in 2 patient groups, including a placebo group

Lidocaine

Active Comparator group

Description:

Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.

Treatment:

Drug: Propofol

Drug: Lidocaine

Normal Saline

Placebo Comparator group

Description:

Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.

Treatment:

Drug: Propofol

Drug: Normal Saline