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NCT01600027
Effects of Dexmedetomidine Addition to Bupivacaine on the Quality of Fascia Iliaca Compartment Block (FICB) in Children Undergoing Femur Fracture Surgery
Phase 1 trial testing Fascia iliaca compartment block in Children With Fracture Femur in 28 participants. Completed in 1 May 2012.
1 March 2012
Quick facts
| Lead sponsor | Mansoura University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 28 |
| Start date | 1 January 2012 |
| Primary completion | 1 March 2012 |
| Estimated completion | 1 May 2012 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Fascia iliaca compartment block — full drug profile →
- Fascia iliaca block — full drug profile →
Conditions studied
- Children With Fracture Femur — all drugs for Children With Fracture Femur →
Sponsor
Mansoura University
Who can join
Adults 2 to 6, any sex, with Children With Fracture Femur. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Postoperative pain scores
Time frame: every 4 hours after surgery
Postoperative using the Objective Pain Scale (children \<6 yr) which described by Hannallah et al.
Sponsor's own description
Fractures of the shaft of femur (FSF) are common in children, especially isolated fractures of the mid-third of the femur which are intensely painful. The pain of the fracture is thought to originate from the femoral shaft periosteum and muscle spasm from the quadriceps mechanism. Fascia iliaca compartment block FIC is easy and simple technique, there is no need for high-skill or expensive equipments. It has higher success rate in more than 90%of the children thigh procedures. Potentially dexmedetomidine has become an alternative to clonidine, it is a highly selective α2 agonist having about an 8-10 times affinity for α2 adrenergic receptors than clonidine and much less α1 effects, which is responsible for the hypnotic and analgesic effects. Perinural dexmedetomidine in combination with bupivacaine or ropivacaine enhance sensory and motor block without neurotoxicity in experimental studies.It has been reported to improve the quality of intrathecal, Epidural, and caudal anesthesia in children. Also, it is safe and effective in IV regional anesthetic and axillary block in adult. No study-up to the date -has been carried to evaluate its effect on the character of fascia iliaca compartment blocks as adjuvant to bupivacaine. The objectives of this study were designed to detect the effects of addition dexmedetomidine (Precedex- Abbot) as adjuvant to bupivacaine for fascia iliaca block on the quality of postoperative analgesia and also to determine its effects on the hemodynamics, recovery behaviors, sedation and possible side effects in children undergoing thigh surgeries (fracture femur).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01600027
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Related trials
Other trials of Fascia iliaca compartment block
Trials testing the same drug.
- NCT06210503 — PENG Block in Comparison With FICB for Hip Reconstruction in Children · NA · active not recruiting
- NCT05154318 — Efficacy of Pericapsular Nerve Group Block · NA · unknown
- NCT04210700 — Comparing Fascia Iliaca Compartment Block and Pericapsular Nerve Group Block for Hip Fracture Pain Control · NA · completed
- NCT04478552 — Analgesic Effect of Fascia Iliaca Compartment Block in Geriatric Patients With Hip Fracture · NA · completed
- NCT04690647 — The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. · NA · completed
Other Mansoura University trials
Trials by the same sponsor.
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- NCT07509567 — Conventional Palatal Crib Versus Bonded Spurs for Anterior Open Bite Treatment · NA · not yet recruiting
- NCT07393178 — Efficacy & Safety of High Power vs. Low Power Holmium Laser in Mini-PCNL for Large Renal Stones · NA · not yet recruiting
- NCT07436182 — Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. · Phase 4 · not yet recruiting
- NCT07534943 — Effectiveness of Oleanolic Acid as Intracanal Medicament on Infectious/Inflammatory Contents in Teeth With Apical Period · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01600027 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mansoura University
- Last refreshed: 15 March 2015
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