Investigation of Apotel, dexamethasone and sublingual buprenorphine with Apotel, dexamethasone and fentanyl in pain control after surgery

Investigation of Apotel, dexamethasone and sublingual buprenorphine with Apotel, dexamethasone and fentanyl in pain control after lower limb fracture surgery with spinal anesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220727055571N1

Enrollment

130

Registered

2023-05-28

Start date

2023-03-21

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Condition 1: pain. Condition 2: nausea and vomiting. Condition 3: anxiety. Pain, unspecified Nausea and vomiting Other anxiety disorders

Interventions

Intervention 1: Intervention group: In this group, a pain pump containing 3 grams of Apotel, 8 mg of dexamethasone and 0.4 buprenorphine sublingually was prescribed every 6 hours in 24 hours. Interven

Eligibility

Sex/Gender

All

Age

15 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age 15-70 years patients with lower limb fracture

Exclusion criteria

Exclusion criteria: History of drug abuse alcohol consumption recent use of tranquilizers, stimulants and antipsychotics antihypertensive drugs calcium channel blockers and history of neuromuscular diseases thyroid disorders history of any type of kidney and heart disease

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: 4at 2, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.	—

Secondary

Measure	Time frame
Nausea and vomiting. Timepoint: at 2, 6, 12 and 24 hours after the operation. Method of measurement: Based on a qualitative review by the following method:1- No nausea and vomiting 2- Nausea 3- Nausea and vomiting one to two times 4- Nausea and vomiting more than 2 times.;Anxiety and restlessness. Timepoint: at 2, 6, 12 and 24 hours after the operation. Method of measurement: According to Ramsey scale (0 to 5): 0 (restless), 1 (calm and alert), 2 (sleepy), 3 (confused but responding to verbal commands), 4 (no response to verbal commands), 5 (absence) response to provocations)).	—

Measure

Time frame

Nausea and vomiting. Timepoint: at 2, 6, 12 and 24 hours after the operation. Method of measurement: Based on a qualitative review by the following method:1- No nausea and vomiting 2- Nausea 3- Nausea and vomiting one to two times 4- Nausea and vomiting more than 2 times.;Anxiety and restlessness. Timepoint: at 2, 6, 12 and 24 hours after the operation. Method of measurement: According to Ramsey scale (0 to 5): 0 (restless), 1 (calm and alert), 2 (sleepy), 3 (confused but responding to verbal commands), 4 (no response to verbal commands), 5 (absence) response to provocations)).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHedye Alsadat Shoaie Moafi

Ardabil University of Medical Sciences

Hedyesh1367@gmail.com+98 45 3327 3461

Outcome results

None listed

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