The Prevention of Pain Associated With Rocuronium Injection
Condition: Injection Site Irritation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether efficacy of different doses of lidocain and
      acetaminophen for the prevention of rocuronium injection pain and frequency of withdrawal
      movements during the general anesthesia induction period.
    

Detailed description: 
      The study was conducted on 150 patients aged 18- 70 years of ASA (American Society of
      Anesthesiologists) physical status I- II who were to undergo various elective operations.
      None of the patients was premedicated before the operation. The patients were monitored with
      three derivation electrocardiogram, non- invasive arterial pressure, and pulse oximeter.

      A 20-gauge catheter was inserted into a superficial vein on the dorsum of the patient's non-
      dominant hand. The lactated Ringer's solution was infused at 100 ml/h for five minutes, The
      infusion was stopped and the arm with the IV line was elevated for 15 seconds for gravity
      drainage of venous blood, The venous drainage was occluded for 120 seconds by using a rubber
      tourniquet on the upper arm and the patients were pretreated by either lidocaine (20 mg and
      40 mg IV) or acetaminophen (50mg and 25 mg IV) before the injection of rocuronium. Some
      patients received 5 ml normal saline. The patients were randomly assigned to five groups. For
      pretreatment the patients were administered 5 ml normal saline in Group I (Control);
      acetaminophen 50mg in Group II, acetaminophen 25 mg in Group III, lidocaine 20 mg in Group IV
      and lidocaine 40mg in Group V, diluted into 5 mL of saline IV. The occlusion was released
      after 120 s and 0.6 mg/kg of rocuronium 1% was injected IV over 5 seconds. During and after
      the injection of rocuronium, pain was graded with four point scale (TEST 1) and withdrawal
      movement was evaluated (TEST 2) by the study-blinded investigator. Twenty seconds after the
      administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal
      intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air.
      Twenty-four hours after the operation, the injection site was checked for any complications,
      such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did
      not know which drug was administered.

      Table 1: Four Point Scala (TEST 1) Degree of pain Response Pain score

        1. None: Negative response to questioning: 0

        2. Mild: Pain reported in response to questioning only, without any behavioral signs: 1

        3. Moderate: Pain reported in response to questioning and accompanied by a behavioral sign,
           or pain reported spontaneously without questioning: 2

        4. Severe: Strong vocal response or response accompanied by facial grimacing, arm
           withdrawal, or tears : 3

      Table 2: Evaluation Of Withdrawal Movements During Rocuronium Injection ( TEST2) Pain Score
      Response

        1. No response

        2. Movement at wrist only

        3. Movement/ withdrawal involving arm only (elbow/ shoulder)

        4. Generalized response ( movement/ withdrawal in more than one extremity, cough or breath
           holding)
    

Intervention name(s): acetaminophen; Lidocaine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm and the patients were pretreated acetaminophen (50mg and 25 mg IV) before the injection of rocuronium.Twenty seconds after the administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air. Twenty-four hours after the operation, the injection site was checked for any complications, such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did not know which drug was administered.; The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm and the patients were pretreated lidocaine (20 mg and 40 mg IV) before the injection of rocuronium.Twenty seconds after the administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air. Twenty-four hours after the operation, the injection site was checked for any complications, such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did not know which drug was administered.; The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm and the patients were pretreated 5 ml iv normal saline before the injection of rocuronium.Twenty seconds after the administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air. Twenty-four hours after the operation, the injection site was checked for any complications, such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did not know which drug was administered.
Other intervention name(s): Parol; Perfalgan; Aritmal % 2; Jetmonal %10; Saline
Intervention MeSH terms: Acetaminophen; Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rocuronium; lidocaine; acetaminophen,; pain; injection