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Safety and efficacy of hydromorphone combined with flurbiprofen on postoperative analgesia in children: A prospective, randomized, muti-center controlled clinical study.

Safety and efficacy of hydromorphone combined with flurbiprofen on postoperative analgesia in children: A prospective, randomized, muti-center controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013935
Enrollment
Unknown
Registered
2017-12-14
Start date
2017-12-31
Completion date
Unknown
Last updated
2018-03-05

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

Conditions

postoperative analgesia in children

Interventions

Group H(0.1mg/kg hydromorphone):postoperative analgesia with 0.1mg/kg/48h of hydromorphine
Group H2(0.2mg/kg hydromorphone):postoperative analgesia with 0.2mg/kg/48h of hydromorphine
Group C(sulfentanyl):postoperative analgesia with 1.5ug/kg/48h of sulfentanyl

Sponsors

Guangzhou Women and Children Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 3 Years

Inclusion criteria

Inclusion criteria: 1) the age was from 6m to 3Y, and the sex was not limited. 2) children who have been anesthetized by tracheal intubation are grade I - II of ASA anesthesia. 3) children undergoing elective abdominal surgery (open or laparoscopic), anorectal surgery, Department of orthopedics surgery, Department of five and Urology; 4) children's parents or legal guardians have signed informed consent

Exclusion criteria

Exclusion criteria: 1) children with hypersensitivity to hydromorphine hydrochloride or a group of anaphylaxis with opioid allergies; 2) preoperative 24h use of sedative and analgesic and antiemetic and anti itch drugs; 3) children with acute upper respiratory tract infection before operation; 4) children with a history of bronchial asthma; 5) children with severe sleep apnea syndrome and children with arrhythmia; 6) history of previous anaesthesia with abnormal surgery; preoperative assessment of the presence or possible existence of difficult airway 7) renal function injury (BUN and / or upper limit of Cr> normal value); liver function injury (ALT and / or AST>1.5 times upper limit of normal value); 8) children with related mental and neurological diseases, which are difficult to evaluate the analgesic effect. 9) children with chronic pain history or long-term use of painkillers; 10) severely obese children or preterm infants who have been corrected for six months of age 11) children with other cases that are considered unsuitable for admission.

Design outcomes

Primary

MeasureTime frame
pain score;remedial administration;

Secondary

MeasureTime frame
Ramsay score;The first remedial time for analgesic administration;Total satisfaction of 48h analgesia;vital signs;

Countries

China

Contacts

Public ContactXingrong Song

Guangzhou Women and Children Medical Center

sxjess@126.com+86 13922416303

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026