Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis
Brief Summary: Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique utilized to diagnose and treat pathologic conditions involving the ducts draining the liver and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and occurs in approximately 11% of children undergoing the procedure. By definition it leads to prolongation of hospital stay or delays in care and rarely can result in long-term morbidity or even death. Recent adult trials have demonstrated prevention of PEP with administration of rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed in children thus no "gold standard" or even commonly accepted method of preventing PEP in the pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages over rectally administered NSAIDs in the pediatric population in that it would allow for more consistent weight based dosing and would have more predictable absorption compared to suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical Center Dallas over a two-year period. The primary outcome measurement will be development of PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease rates of post-ERCP pancreatitis in pediatric patients.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Ibuprofen; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ibuprofen | Arm Label: TRAM.HCl high dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tramadol Hydrochloride | Arm Label: TRAM.HCl low dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tramadol Hydrochloride | Arm Label: DKP-TRIS high dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dexketoprofen Trometamol | Arm Label: DKP-TRIS low dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dexketoprofen Trometamol | Arm Label: DKP-TRIS low dose - TRAM.HCl low dose; Type: EXPERIMENTAL; Interventions: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride | Arm Label: DKP-TRIS low dose - TRAM.HCl high dose; Type: EXPERIMENTAL; Interventions: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride | Arm Label: DKP-TRIS high dose - TRAM.HCl low dose; Type: EXPERIMENTAL; Interventions: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride | Arm Label: DKP-TRIS high dose - TRAM.HCl high dose; Type: EXPERIMENTAL; Interventions: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride | Intervention Type: DRUG; Name: Dexketoprofen Trometamol; Assigned to Arm(s): DKP-TRIS low dose | Intervention Type: DRUG; Name: Dexketoprofen Trometamol; Assigned to Arm(s): DKP-TRIS high dose | Intervention Type: DRUG; Name: Tramadol Hydrochloride; Assigned to Arm(s): TRAM.HCl low dose | Intervention Type: DRUG; Name: Tramadol Hydrochloride; Assigned to Arm(s): TRAM.HCl high dose | Intervention Type: DRUG; Name: Ibuprofen; Assigned to Arm(s): Ibuprofen | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Dexketoprofen Trometamol + Tramadol Hydrochloride; Assigned to Arm(s): DKP-TRIS low dose - TRAM.HCl low dose | Intervention Type: DRUG; Name: Dexketoprofen Trometamol + Tramadol Hydrochloride; Assigned to Arm(s): DKP-TRIS low dose - TRAM.HCl high dose | Intervention Type: DRUG; Name: Dexketoprofen Trometamol + Tramadol Hydrochloride; Assigned to Arm(s): DKP-TRIS high dose - TRAM.HCl low dose | Intervention Type: DRUG; Name: Dexketoprofen Trometamol + Tramadol Hydrochloride; Assigned to Arm(s): DKP-TRIS high dose - TRAM.HCl high dose
B: Arm Label: caldolor; Type: EXPERIMENTAL; Interventions: Drug: ibuprofen (caldolor 10 mg / kg) | Arm Label: denogan; Type: ACTIVE_COMPARATOR; Interventions: Drug: propacetamol (denogan 30 mg / kg) | Arm Label: combination; Type: EXPERIMENTAL; Interventions: Drug: ibuprofen + propacetamol | Intervention Type: DRUG; Name: ibuprofen (caldolor 10 mg / kg); Assigned to Arm(s): caldolor | Intervention Type: DRUG; Name: propacetamol (denogan 30 mg / kg); Assigned to Arm(s): denogan | Intervention Type: DRUG; Name: ibuprofen + propacetamol; Assigned to Arm(s): combination
C: Arm Label: Ibuprofen; Type: EXPERIMENTAL; Interventions: Drug: Ibuprofen | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Ibuprofen; Assigned to Arm(s): Ibuprofen | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo
D: Arm Label: Therapeutic; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ibuprofen | Arm Label: Prophylactic; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ibuprofen | Intervention Type: DRUG; Name: Ibuprofen; Assigned to Arm(s): Prophylactic, Therapeutic

Answer: C