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Evaluation of the Efficacy of Dipyrone, administered before the surgical incision, in postoperative Pain after Tonsil and Adenoid surgeries in children

Evaluation of the efficacy of Dipirone in Preemptive Analgesia through decreasing pain after Adenotonsylectomy operation in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9gzgpb
Enrollment
Unknown
Registered
2019-10-14
Start date
2019-03-27
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

Pain post operative

Interventions

76 patients will be randomly distributed through envelopes, one for each group, randomization will be in two blocks: intervention and control. The medications will be prepared by a pharmacist and admi
In the awakening of anesthesia, also intravenous, Morphine and Ondasetrona. Group 2 (control) and: In the anesthetic induction will be administered intravenously, Dexamethasone, Clonidine and Placebo
In the awakening of anesthesia, also intravenous, Morphine and Ondasetrona.

Sponsors

Hospital da Criança Santo Antônio
Lead Sponsor
Hospital da Criança Santo Antônio
Collaborator

Eligibility

Age
4 Years to 14 Years

Inclusion criteria

Inclusion criteria: Children between 4 and 14 years old, ASA (American Society of Anesthesiology) physical status I (healthy patient) and II (patient with mild illnesses); with scheduling of first tonsillectomy surgery with or without adenoidectomy; who had a consent form signed by the responsible person and the consent form, when necessary.

Exclusion criteria

Exclusion criteria: Those patients who had already undergone adenoidectomy surgery; with any chronic illness that requires daily fixed analgesia; with developmental delay; who did not understand the Portuguese language, who did not have parents living with them and those who perhaps they did not accept participation in the study.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: To evaluate postoperative pain in children undergoing adenotonsillectomies, according to the pharmacological intervention group (dipyrone or placebo), using validated scales: "Children's and Infants'Postoperative Pain Scale" and "Visual Analog Scale", in the recovery room post anesthetic, at H0 (patient arrival); at H1 (in 1 hour); in H3 (in 3 hours) and in H6 (in 6 hours).;Outcome found 1: Postoperative pain remained controlled in at least 77.6% of children in relation to all moments verified (H0, H1, H2, H3 and H6), in the intervention group. Analyzing the intervention and placebo groups, it was evident that the proportion in pain control was 54.2% versus 45.8%, respectively, showing the greatest difference in the H3 moment between the stages evaluated.

Secondary

MeasureTime frame
Expected outcome 2: Compare the need to use rescue opioids in the postoperative period between the intervention and placebo groups, according to doses administered during the stay in the recovery room. ;Outcome found 2: A reduction in the need for the use of rescue opioids in the postoperative period was observed in the intervention group, ranging from 6 to 9% fewer doses administered during the stay in the recovery room.

Countries

Brazil

Contacts

Public ContactMaira Isis dos Stangler

Hospital da Criança Santo Antônio

mairastangler@yahoo.com.br+55(051)991133842

Outcome results

None listed

Source: REBEC (via WHO ICTRP)