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Comparison of ketamine /propofol Versus ketamine/Thiopental in Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation

Comparison of ketamine /propofol Versus ketamine/Thiopental in Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200809048341N1
Enrollment
90
Registered
2020-11-23
Start date
2020-11-28
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Sedational analgesia for Reduction of Anterior Shoulder Dislocation. Subluxation and dislocation of shoulder joint

Interventions

Intervention 1: Intervention group 1: First, we inject 30 mg of ketorolac intravenously in all patients for 30 minutes 15 minutes before prescribing other drugs. We then inject 1 mg of midazolam intr
We start reduction when the patient has a RASS score of -4. After sedation, reduction is performed by Liddell Meyer method and Milch alternative method is considered. In case of nausea, vomiting of

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy patients without previous disease and those with mild systemic disease without functional limitations according to the American Society of Anesthesiologist classification (individuals 1 and 2) Those who have been NPOs ( Nil Per Os) or consumed fluids in the last 3 hours Those that do not need to be reduced in the operating room. Age 18 to 64 years

Exclusion criteria

Exclusion criteria: Any contraindications including asthma and COPD(chronic obstructive pulmonary disease), systolic blood pressure below 90 or above 180, ischemic heart disease or heart failure, any symptoms in favor of increased intracranial pressure, glaucoma, psychosis and use of any psychotropic substances, acute or chronic alcoholism, liver or kidney failure, Allergies to any of the drugs studied or eggs or soy, people addicted to drugs, taking any sedatives or anesthetics before going to the emergency room, obstructive sleep apnea syndrome, maxillofacial malformations that block the airway, Pregnancy, dislocations lasting more than 24 hours, multiple trauma or hemodynamic instability, history of uncontrollable seizures, and patients who do not wish to participate in the study

Design outcomes

Primary

MeasureTime frame
Time to appropriate sedation. Timepoint: 3 minutes after the last drug injection. Method of measurement: physical examination.;The duration of the effect of the drug. Timepoint: 15 minutes after drug injection. Method of measurement: Physical examination.;Discharge time. Timepoint: 15 minutes after drug infection. Method of measurement: Physical examination.;The pain before reduction. Timepoint: before starting reduction. Method of measurement: By the visual analog scale.;Need to additional doses of medication. Timepoint: 3 minutes after the last injection. Method of measurement: Physical examination.;Incidence of any side effects. Timepoint: Before injecting the drug and every 5 minutes. Method of measurement: Physical examination and vital signs.;Pain during reduction. Timepoint: During reduction. Method of measurement: By the facial pain scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Hajisafari Tafti

Yazd University of Medical Sciences

Z.hajisafaritafti@gmail.com+98 35 3263 5841

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026