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. 2017 Jun 1;2017(6):CD006476. doi: 10.1002/14651858.CD006476.pub3

Franken 1983.

Methods
  • Study design: randomised controlled trial; 2‐arm study

  • Study duration: not stated

Participants
  • Setting: not stated

  • Location: not stated

  • Health status: referred for reduction of ileocolic intussusception

  • Number (treatment group/control group): 30 (15/15)

  • Age: 3 years or younger

  • Sex (M/F): not stated

  • Exclusion criteria: suspicion of attending physician of peritonitis, clinical or radiographic evidence of peritonitis or intestinal perforation, radiographic evidence of small‐bowel obstruction, indication that intussusception had been present for over 48 hours, fever over 40° C, hypovolaemic shock, blood loss anaemia (haemoglobin < 80 g/L), contraindication to administration of glucagon (suspected pheochromocytoma, insulinoma, glucagon sensitivity, or uncontrolled diabetes)

Interventions Treatment group
  • Glucagon: 0.05 mg/kg with barium enema injected IV (over 1 minute) when intussusception was identified at fluoroscopy


Control group
  • Placebo: 0.05 mg/kg with barium enema injected IV when intussusception was identified at fluoroscopy

Outcomes
  • Reduction of intussusception by barium enema

  • Failure of procedure at the end of the time limit, but ultimately successful hydrostatic reduction

  • Failure of procedure, but intussusception reduced at surgery

  • Failure of procedure, and intussusception un‐reduced at surgery

Notes Procedure details: The enema consisted of barium sulphate suspension of approximately 20% w/v concentration, with the enema bag 1 metre above the table top. The enema could be repeated twice more if the initial attempt failed (i.e. lack of reduction within 5 minutes)
Other details: Glucagon and placebo were supplied by the Eli Lilly Company
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "The injections were given in randomized, double‐blind fashion"; no further details supplied
Allocation concealment (selection bias) Unclear risk "The injections were given in randomized, double‐blind fashion"; no further details supplied
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing data (randomisation post exclusion)
Selective reporting (reporting bias) Low risk Reporting included all outcomes and explained outcomes that were unexpected: "eight of 15 intussusceptions...were successfully reduced" ‐ "two patients in the study suffered complications of intussusception...before full recovery ensued"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "The injections were given in randomized, double‐blind fashion...Glucagon and the placebo were supplied in identical vials"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not specified who assessed outcomes