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Effect of esketamine combined with sufentanil on postoperative acute pain in burn patients : A randomized controlled trial

Effect of esketamine combined with sufentanil on postoperative acute pain in burn patients : A randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058748
Enrollment
Unknown
Registered
2022-04-16
Start date
2022-05-15
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

acute postoperative pain

Interventions

Esketamine group:Esketamine + sufentanil
Control group:sufentanil

Sponsors

The General Hospital of Northen Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Burn patients (TBSA > 10%) admitted to the General Hospital of the Northern Warfare Zone; 2. ASA grade II - III; 3. Age = 18 years, weight 50-100kg, regardless of gender; 4. It is planned to perform debridement, escharectomy, skin grafting, etc. under general anesthesia; 5. Pain score = 2 points without using analgesics before operation; 6. The patient controlled analgesia was used independently; 7. Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Known allergy to active ingredients or excipients of Esketamine Hydrochloride Injection; 2. It is estimated that the patient will be transferred to ICU with endotracheal tube after operation; 3. Have serious cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, endocrine diseases or liver and kidney dysfunction; 4. Risk of elevated blood pressure, intraocular pressure (such as glaucoma) and intracranial pressure; 5. Complicated with nervous or mental diseases; 6. Alcoholism or long-term use of sedatives and analgesics before admission; 7. Those who have operated or used the test drug within one week before the operation; 8. Those who have participated in clinical trials of other drugs as subjects in recent 3 months; 9. Communication barriers (dyslexia in reading and writing Chinese, language barrier, visual impairment or hearing impairment, etc.) cannot cooperate in completing the research; 10. Those who refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
NRS pain score;

Secondary

MeasureTime frame
Dosage of rescue analgesics in 48h after operation;The incidence of adverse reactions within 48 hours after surgery;Depression and anxiety scores and cognitive function changes before and after surgery;Postoperative sedation score (OAA/S score);Patients' satisfaction with analgesic intervention within 48 hours;

Countries

China

Contacts

Public ContactYingjie Sun

The General Hospital of Northen Theater Command

sunyingjie9@hotmail.com+86 17790993787

Outcome results

None listed

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