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Comparison between the effect of two analgesics on sedation in surgeries in children who fractured the upper limb

Comparasion between Fentanyl and Ketamine in the intra-operative sedation of children submitted to orthopedic procedures in upper limb -

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-4q6dtvw
Enrollment
Unknown
Registered
2021-11-05
Start date
2021-01-02
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Bone and Bones

Interventions

Participants will be randomized into two groups. The study drug solutions (ketamine or fentanyl solution as determined by the application) will be prepared in coded syringes and labeled by a specializ
C05.550.518.336

Sponsors

Universidade de Fortaleza - Unifor
Lead Sponsor
Universidade de Fortaleza - Unifor
Collaborator

Eligibility

Age
24 Months to No maximum

Inclusion criteria

Inclusion criteria: Children aged between 24 and 192 months. Both genders. Undergoing a surgical procedure for correction of upper limb fractures. No major comorbidities.

Exclusion criteria

Exclusion criteria: Allergy to some medication used in the study. Chronic use of sedatives or analgesics. Previous neurological or motor deficits. Use of alcohol or drugs.

Design outcomes

Primary

MeasureTime frame
Ventilatory depression. The presence of ventilatory depression will be considered if there is an episode of apnea or peripheral oxygen saturation below 90% during monitoring. Data collected during the surgical procedure and in the first 30 minutes of the postoperative period.

Secondary

MeasureTime frame
Pain. Pain will be measured using an appropriate scale (Hanallah Scale). Scores greater than six will be considered postoperative pain. The measurement will take place within the first 30 minutes of the postoperative period, in the anesthetic recovery room.;Delirium. The occurrence of postoperative delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium scale. A score greater than ten will be the diagnostic criterion. The measurement will take place within the first 30 minutes of the postoperative period, in the anesthetic recovery room.;Nausea and vomiting. The occurrence of nausea and vomiting will be noted during the surgical procedure and in the first 30 minutes of the postoperative period.

Countries

Brazil

Contacts

Public ContactFelipe Marques
felipeufc@gmail.com+55(85)996730941

Outcome results

None listed

Source: REBEC (via WHO ICTRP)