Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia

NCT ID: NCT01858402

Last Updated: 2013-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-07-31

Brief Summary

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We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.

Detailed Description

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The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.

Conditions

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Other Acute Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Paracetamol

15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose

Dipyrone

15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose

Group Type ACTIVE_COMPARATOR

Dipyrone

Intervention Type DRUG

15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose

Interventions

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Paracetamol

15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose

Intervention Type DRUG

Dipyrone

15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose

Intervention Type DRUG

Other Intervention Names

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Parol Metamizole

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery

Exclusion Criteria

* increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Esra Caliskan

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Caliskan E, Sener M, Kocum A, Ozyilkan NB, Ezer SS, Aribogan A. The efficacy of intravenous paracetamol versus dipyrone for postoperative analgesia after day-case lower abdominal surgery in children with spinal anesthesia: a prospective randomized double-blind placebo-controlled study. BMC Anesthesiol. 2013 Oct 22;13(1):34. doi: 10.1186/1471-2253-13-34.

Reference Type DERIVED
PMID: 24144215 (View on PubMed)

Other Identifiers

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KA 09/06

Identifier Type: -

Identifier Source: org_study_id

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