Clinical trial NCT04555980: Warm Patch Decrease Propofol Injection Pain
Official title: Will Warm Patch on the Injecting Site Decrease the Injection Pain Induced by Propofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Syndrome
Propofol Infusion Syndrome
Injection Site Irritation
Keywords: propofol,injection,pain
Lead sponsor: First People's Hospital of Chenzhou
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group W : the injection site was covered with warm patch. Group C: the injection site was covered with Cotton patch.
Primary purpose: PREVENTION

Brief summary: Propofol causes injection pain is still a common clinical unsolved problem. Mixing a small amount of lidocaine with propofol or injecting lidocaine in advance can reduce the pain caused by propofol injection. Using an air warmer to warm the arm can also reduce the pain caused by propofol injection. Investors suspect that treatment with a warming patch (covering the injection site) can also reduce the pain caused by propofol injection.

Detailed description: This is a single-center randomized controlled clinical study. Purpose of this study is to explore whether the coverage of the warming patch (for 5min before injection) can reduce the pain induced by propofol injection.

The patients included in the study were randomly divided into two groups. The group W used a warming patch to cover the injection site, and the group C used a cotton pad to cover the injection site. After 5 minutes of coverage, the propofol injection was induced, and the patient's complaint of pain (calling or arm withdrawal) during propofol injection was observed, and the patient's recall of the pain score during induction after the patient recovered. After the patients regained consciousness, the data of the two groups were compared to determine whether the use of the warming patch could reduce the pain caused by propofol injection.

Eligibility criteria: Inclusion Criteria:

* No peripheral phlebitis
* No history of Raynaud's syndrome
* No history of smoking or alcoholism
* Body mass index BMI\<28 kg/cm2

Exclusion Criteria:

* Refusal of anesthesia
* Previous injection pain caused by propofol
* Difficulty in exposing the veins on the back of the hand or difficulty in venipuncture
* Complained of pain after normal saline infusion.

Primary outcomes:
measure: Arm withdrawn
timeFrame: 5min
measure: Complaints of pain
timeFrame: 5min
measure: Pain score after awakening from propofol
timeFrame: 10min
Secondary outcomes:
measure: Respiratory depression
timeFrame: 5min
measure: Temperature of injection site after injecting of propofol.
timeFrame: 10min
Other outcomes:
Locations:
city: Chenzhou
country: China
facility: Zhiming Zhang
state: Hunan
Study officials:
References:
citation: Jeong M, Yoon H. Comparison of the effects of lidocaine pre-administration and local warming of the intravenous access site on propofol injection pain: Randomized, double-blind controlled trial. Int J Nurs Stud. 2016 Sep;61:209-18. doi: 10.1016/j.ijnurstu.2016.06.012. Epub 2016 Jun 24.
citation: Euasobhon P, Dej-Arkom S, Siriussawakul A, Muangman S, Sriraj W, Pattanittum P, Lumbiganon P. Lidocaine for reducing propofol-induced pain on induction of anaesthesia in adults. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD007874. doi: 10.1002/14651858.CD007874.pub2.
citation: Lang BC, Yang CS, Zhang LL, Zhang WS, Fu YZ. Efficacy of lidocaine on preventing incidence and severity of pain associated with propofol using in pediatric patients: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Mar;96(11):e6320. doi: 10.1097/MD.0000000000006320.