Comparison of three drugs: gabapentin, celecoxib, and mirtazapine in preventing itching after spinal anesthesia in patients undergoing hip fracture repair surgery.

Comparison of the preventive effect of Gabapentin, Celecoxib and Mirtazapine in pruritus caused by intrathecal fentanyl in patients undergoing femoral fracture repair surgery.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191104045328N40

Enrollment

Registered

2025-08-25

Start date

2025-09-06

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Post-spinal anesthesia pruritus. Pruritus

Interventions

Intervention 1: Celecoxib group: Patients in this group receive 400 mg of celecoxib (two 200 mg capsules) orally one hour before surgery. The intervention drug was administered orally with 10 mL of wa

Exir Pharmaceutical Company, Iran). The intervention drug was administered orally with 10 mL of water, one hour before surgery. Intervention 3: Mirtazapine group: Patients in the mirtazapine group rec

Actoverco, Iran). The intervention drug was administered orally with 10 mL of water, one hour before surgery.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for femur fracture repair surgery Surgery on one side (one leg) Having informed consent to participate in the study Surgery performed by a surgeon

Exclusion criteria

Exclusion criteria: Having systemic diseases including kidney, liver, cardiovascular, high blood pressure, diabetes, or malignancy. Having a history of drug or chronic pain medication use, skin conditions with widespread itching, or any itching prior to surgery.

Design outcomes

Primary

Measure	Time frame
Itching score. Timepoint: In the recovery room and every 2 hours postoperatively for up to 12 hours. Method of measurement: Visual analog scale.;Ramsey Score. Timepoint: Following administration of the intervention drug, assessments were performed every 15 minutes until the end of surgery, in the recovery room, and subsequently every 2 hours for up to 12 hours postoperatively. Method of measurement: By registering the Ramsey Score.	—

Measure

Time frame

Itching score. Timepoint: In the recovery room and every 2 hours postoperatively for up to 12 hours. Method of measurement: Visual analog scale.;Ramsey Score. Timepoint: Following administration of the intervention drug, assessments were performed every 15 minutes until the end of surgery, in the recovery room, and subsequently every 2 hours for up to 12 hours postoperatively. Method of measurement: By registering the Ramsey Score.

—

Secondary

Measure	Time frame
Mean arterial pressure. Timepoint: Immediately after the intervention, assessments were conducted every 5 minutes during the first 30 minutes and subsequently every 15 minutes until the end of surgery. Method of measurement: Cardiac monitoring.;Heart rate. Timepoint: Immediately after the intervention, assessments were conducted every 5 minutes during the first 30 minutes and subsequently every 15 minutes until the end of surgery. Method of measurement: Cardiac monitoring.;Arterial blood oxygen saturation. Timepoint: Immediately after the intervention, assessments were conducted every 5 minutes during the first 30 minutes and subsequently every 15 minutes until the end of surgery. Method of measurement: Cardiac monitoring.	—

Measure

Time frame

Mean arterial pressure. Timepoint: Immediately after the intervention, assessments were conducted every 5 minutes during the first 30 minutes and subsequently every 15 minutes until the end of surgery. Method of measurement: Cardiac monitoring.;Heart rate. Timepoint: Immediately after the intervention, assessments were conducted every 5 minutes during the first 30 minutes and subsequently every 15 minutes until the end of surgery. Method of measurement: Cardiac monitoring.;Arterial blood oxygen saturation. Timepoint: Immediately after the intervention, assessments were conducted every 5 minutes during the first 30 minutes and subsequently every 15 minutes until the end of surgery. Method of measurement: Cardiac monitoring.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ismaeil Moshiri

Arak University of Medical Sciences

moshiri_e@yahoo.com+98 86 3222 2003

Outcome results

None listed

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