Clinical trial NCT02512783: Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation
Official title: Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Propofol
Lidocaine
Intravenous propofol
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 171
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score
timeFrame: 1 minute before propofol induction compared to 1 minute following propofol induction
Secondary outcomes:
measure: Parental Assessment of Child's Pain on a Visual Analog Scale
timeFrame: Immediately following propofol injection
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: Didima Mon-Sprehe, MD
role: PRINCIPAL_INVESTIGATOR
References: