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Efficacy and safety of hydromorphine hydrochloride combined with flurbiprofen axetil for postoperative analgesia in children

AnesthesiologyEfficacy and safety of hydromorphine hydrochloride combined with flurbiprofen axetil for postoperative analgesia in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029193
Enrollment
Unknown
Registered
2020-01-18
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-01-20

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

Conditions

Hypospadias in children

Interventions

Group H1 (hydromorphone group 1):Hydromorphone 0.1mg/kg + flurbiprofen ester 5mg / kg
Group H2 (hydromorphone group 2):Hydromorphone 0.2mg/kg + flurbiprofen ester 5mg / kg
Group C (sufentanil group):Sufentanil 1.5ug/kg

Sponsors

Xiamen Maternal and Child Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
0.5 Years to 3 Years

Inclusion criteria

Inclusion criteria: 1) Aged 6 months to 3 years; 2) ASA I, or II in the children who were to be general anesthesia by tracheal intubation; 3) Children who have abdominal surgery (open or laparoscopic), orthopedic surgery, facial features surgery and urology surgery; 4) The parent or legal guardian of the child has signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) Those who are allergic to flurbiprofen ester, hydromorphone hydrochloride or its components, and children who have a history of opioid allergy; 2) 24 hours before the operation, analgesics, antiemetics, anti pruritus and quinolones were used; 3) Children with acute upper respiratory tract infection before operation; 4) Children with a history of asthma; 5) Children with severe sleep apnea syndrome and arrhythmia; 6) Previous abnormal operation anesthesia recovery history; preoperative evaluation of the presence or possible presence of difficult airway; 7) Renal function damage (BUN and / or Cr > the upper limit of normal value), liver function damage (ALT and / or ast > 1.5 times the upper limit of normal value); 8) It is difficult to evaluate the analgesic effect of children with related mental and neurological diseases; 9) Children with a history of chronic pain or taking painkillers for a long time; 10) Children with severe obesity or preterm infants less than six months of corrected age 11) Patients with other conditions considered unsuitable by the researchers.

Design outcomes

Primary

MeasureTime frame
Postoperative FLACC score;

Secondary

MeasureTime frame
Sedation Ramsay score;

Countries

China

Contacts

Public ContactJia Junxiang

Xiamen Maternal and Child Care Hospital

binger779@163.com+86 15980965934

Outcome results

None listed

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