Injection Site IrritationPhase 4NCT02524743
The Prevention of Pain Associated With Rocuronium Injection
A Phase 4 study testing acetaminophen and Lidocaine in people with Injection Site Irritation, run by Suleyman Demirel University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Irritation
- What is being tested?
- acetaminophen and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18- 70 years of ASA physical status I- II who were to undergo various elective operations.
Who cannot join
- Patients with chronic pain syndrome,
- Patients with neurologic deficits,
- Patients with thrombophlebitis,
- Patients with difficult venous access,
- Patients with allergy
About this study
Official title: The Prevention of Pain Associated With Rocuronium Injection: Effect of Pretreatment With Acetaminophen and Lidocaine
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.
Read the 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
- None: Negative response to questioning: 0
- Mild: Pain reported in response to questioning only, without any behavioral signs: 1
- Moderate: Pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning: 2
- 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
- No response
- Movement at wrist only
- Movement/ withdrawal involving arm only (elbow/ shoulder)
- Generalized response ( movement/ withdrawal in more than one extremity, cough or breath holding)
- Conditions
- Injection Site Irritation
- Being tested
- acetaminophen, Lidocaine, Placebo
- Keywords
- Rocuronium, lidocaine, acetaminophen,, pain, injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophenDrug
Also called Parol, Perfalgan
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.
LidocaineDrug
Also called Aritmal % 2, Jetmonal %10
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.
PlaceboOther
Also called Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Group I) | Placebo comparator | For pretreatment the patients were administered IV 5ml normal saline.
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. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator Receives: Other: Placebo |
| Group II | Active comparator | For pretreatment the patients were administered IV acetaminophen 50 mg
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. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator Receives: Drug: acetaminophen |
| Group III | Active comparator | For pretreatment the patients were administered IV acetaminophen 25 mg.
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. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator Receives: Drug: acetaminophen |
| Group IV | Active comparator | For pretreatment the patients were administered IV lidocaine 20 mg
The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator Receives: Drug: Lidocaine |
| Group V | Active comparator | For pretreatment the patients were administered IV lidocaine 40 mg.
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. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intraoperative pain
pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2)
Measured: 10 seconds
Secondary outcomes (1)
Change in postoperative pain
Twenty-four hours after the operation, the injection site was checked for any complications, such as pain, swelling or allergic reaction
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Injection Site IrritationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Alkaya Solmaz, Suleyman Demirel University
- Investigators
- Filiz Alkaya Solmaz, Principal investigator, Suleyman Demirel University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524743
- Sponsor's protocol ID
- 02.04.2014/48
- Status last verified
- Aug 2015
- First submitted
- 5 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Steegers MA, Robertson EN. Pain on injection of rocuronium bromide. Anesth Analg. 1996 Jul;83(1):203. doi: 10.1097/00000539-199607000-00065. No abstract available.
PubMed 8659757Kwak HJ, Kim JY, Kim YB, Min SK, Moon BK, Kim JY. Pharmacological prevention of rocuronium-induced injection pain or withdrawal movements: a meta-analysis. J Anesth. 2013 Oct;27(5):742-9. doi: 10.1007/s00540-013-1595-7. Epub 2013 Mar 22.
PubMed 23519582
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevention of Pain Associated With Rocuronium Injection: Effect of Pretreatment With Acetaminophen and Lidocaine
- ClinicalTrials.gov ID
- NCT02524743
- Acronym / sponsor ID
- 02.04.2014/48
- Conditions
- Injection Site Irritation
- Keywords
- Rocuronium, lidocaine, acetaminophen,, pain, injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- None: Negative response to questioning: 0
- Mild: Pain reported in response to questioning only, without any behavioral signs: 1
- Moderate: Pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning: 2
- 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
- No response
- Movement at wrist only
- Movement/ withdrawal involving arm only (elbow/ shoulder)
- Generalized response ( movement/ withdrawal in more than one extremity, cough or breath holding)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo (Group I) | Placebo comparator | Other: PlaceboFor pretreatment the patients were administered IV 5ml normal saline. 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. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator |
| Group II | Active comparator | Drug: acetaminophenFor pretreatment the patients were administered IV acetaminophen 50 mg 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. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator |
| Group III | Active comparator | Drug: acetaminophenFor pretreatment the patients were administered IV acetaminophen 25 mg. 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. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator |
| Group IV | Active comparator | Drug: LidocaineFor pretreatment the patients were administered IV lidocaine 20 mg The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator |
| Group V | Active comparator | Drug: LidocaineFor pretreatment the patients were administered IV lidocaine 40 mg. 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. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18- 70 years of ASA physical status I- II who were to undergo various elective operations.
Key exclusion criteria (5 listed)
- Patients with chronic pain syndrome,
- Patients with neurologic deficits,
- Patients with thrombophlebitis,
- Patients with difficult venous access,
- Patients with allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophenAlso: Parol, PerfalganThe 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. | Drug | Group II, Group III |
| LidocaineAlso: Aritmal % 2, Jetmonal %10The 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. | Drug | Group IV, Group V |
| PlaceboAlso: SalineThe 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 | Placebo (Group I) |
Primary outcome
Change in intraoperative pain
Time frame: 10 seconds
pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2)
1 secondary outcome
Change in postoperative pain
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Background: PubMed 8659757Steegers MA, Robertson EN. Pain on injection of rocuronium bromide. Anesth Analg. 1996 Jul;83(1):203. doi: 10.1097/00000539-199607000-00065. No abstract available.
- Background: PubMed 23519582Kwak HJ, Kim JY, Kim YB, Min SK, Moon BK, Kim JY. Pharmacological prevention of rocuronium-induced injection pain or withdrawal movements: a meta-analysis. J Anesth. 2013 Oct;27(5):742-9. doi: 10.1007/s00540-013-1595-7. Epub 2013 Mar 22.
- SpringerLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz Alkaya Solmaz principal investigator
Suleyman Demirel University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetaminophen and Lidocaine in people with Injection Site Irritation, run by Suleyman Demirel University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intraoperative pain (time frame: 10 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524743, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.