Clonidine for Tourniquet-related Pain in Children: A Pilot Study

Status: Unknown
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study is designed as a randomized, placebo-controlled, double-blinded, clinical trial with two parallel groups. This study investigates the association between a single dose of the drug, Clonidine, and the total amount of opioid administered under and 24 hours after surgery in children undergoing orthopedic limb surgery with the use of tourniquet. The investigators hypothesize that administration of clonidine to children undergoing limb surgery with the use of inflatable tourniquets would reduce post-procedural pain. This study is a pilot to obtain an effect size. Based on this the investigators will calculate a sample size for the main trial enabling us to reach a power of 0.8 with a significans level of 0.05.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 15
Healthy Volunteers: t
View:

• ASA I + II

• Scheduled for GA and planned for relevant surgical procedure (according to table 1)

• Planned use of surgical tourniquet on upper and/or lower extremity

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Nicola G. Clausen, Ph.D.
nicola.groes.clausen2@rsyd.dk
0045 65 41 25 47
Time Frame
Start Date: 2021-03-01
Completion Date: 2022-01-01
Participants
Target number of participants: 20
Treatments
Placebo_comparator: Control group
IV Saline (Natriumklorid B.Braun 9mg/ml, B.Braun Melsungen AG, Melsungen, Tyskland) in an equal quantity as the study drug is administered at tourniquet inflation
Experimental: Intervention group
Catapressan (CatapresR Ampoules 150 micrograms in 1ml, Solution for injection, Boehringer Ingelheim Ltd., Berkshire, UK)(3mcg/kg) is administered at tourniquet inflation
Sponsors
Leads: Odense University Hospital
Collaborators: Odense Patient Data Explorative Network

This content was sourced from clinicaltrials.gov

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