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Investigating the outcome and side effects of intrathecal morphine injection in posterior fusion surgery of patients with idiopathic scoliosis

Investigating the outcome and side effects of intrathecal morphine injection in posterior fusion surgery of patients with idiopathic scoliosis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240217061034N1
Enrollment
60
Registered
2024-04-12
Start date
2024-04-19
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Outcome and complications of intrathecal morphine injection in posterior fusion surgery of patients with idiopathic scoliosis. Infantile idiopathic scoliosis

Interventions

Intervention 1: 3 micrograms per kilogram of body weight, morphine of Daro Parseh Tehran Company will be injected intratracheally before anesthesia
Intrathecal injection of morphine is a less complicated process
In case of blood pressure drop, serum will be injected and naloxone will be injected in case of itching. Intervention 2: Control group: Routine treatment will be done.

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 20 Years

Inclusion criteria

Inclusion criteria: Patients in need of posterior fusion surgery, patients with idiopathic scoliosis referred to Imam Khomeini Hospital , 10 to 20 years old with physical status I, II, American Society of Anesthesiologists (ASA) Children with idiopathic scoliosis in the range of 10 to 20 years

Exclusion criteria

Exclusion criteria: Symptoms of L2-3 intervertebral nerve injury Known allergy to one or more drugs used in the study protocol History of corticosteroid use Opium and NSAIDs in at least one week Coagulation dysfunction, infection at the puncture site Cognitive impairment (inability to understand VAS) Body mass index (BMI) greater than 35 kg/m2

Design outcomes

Primary

MeasureTime frame
Pain intensity based on the pain felt by the patient. Timepoint: In recovery, it will be evaluated 0 to 2, 2 to 6, 6 to 12, and 12 to 24 hours after the operation. Method of measurement: pain scale (VAS).;Nausea/vomiting/itching. Timepoint: In recovery, it will be evaluated 0 to 2, 2 to 6, 6 to 12, and 12 to 24 hours after the operation. Method of measurement: Physical examination.;The first time to ask for painkillers. Timepoint: 24 hours after the operation. Method of measurement: Painkiller request by the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Mir Bahram Safari

Oroumia University of Medical Sciences

safari.mb@umsu.ac.ir0098443469931

Outcome results

None listed

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