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Comparing the time of extubation, postoperative apnea incidence, and the quality of perioperative analgesia in infants scheduled for pyloromyotomy- Intravenous bolus fentanyl vs rectal acetaminophen

Comparing the time of extubation, postoperative apnea incidence, and the quality of perioperative analgesia in infants scheduled for pyloromyotomy-intravenous bolus fentanyl vs rectal acetaminophen

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180726040601N1
Enrollment
20
Registered
2018-09-24
Start date
2017-02-19
Completion date
Unknown
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Pyloric Stenosis. Digestive system disorders of fetus and newborn

Interventions

Intervention 1: Control group: Infants with Hypertrophic Pyloric Stenosis witch are candidate for surgery
in this group we use Fentanyl as a pain relief . in Fentanyl group we will use Fentanyl (1µg/kg) with Midazolam .in both groups the time of discharge from recovery and the number of apneas that happen
in this group we use rectal Acetaminophen as a pain relief. in acetaminophen group we will use rectal Acetaminophen ( 40mg/kg) before Midazolam .

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Days to 2 Months

Inclusion criteria

Inclusion criteria: Infants with Hypertrophic Pyloric Stenosis Having no other problem

Exclusion criteria

Exclusion criteria: Age more than 2 months Weight less than 2.5 kg Preterm labor Serum Hg less than 10mg/dl Serum bicarbonate more than 30mmol/l Serum pH more than 55mmol/L Using muscle relaxants

Design outcomes

Primary

MeasureTime frame
Knowing that patients with Hypertrophic Pyloric Stenosis are at risk of long recovery and apnea after surgery? deleting drugs that cause this effect like Fentanyl and replacing it with Acetaminophen witch dose not have this effect will be useful .(in case of having same pain relief effect ) . in both groups the time of discharging from recovery and the number of apneas that happens in recovery after extubation will be recorded and the effects of this two drugs will be compared at the end . Timepoint: In Fentanyl group we use Fentanyl as a pain relief with Midazolam and in Acetaminophen group we use rectal Acetaminophen 20-30 min before Midazolam . Method of measurement: Recovery time with watch -Apnea with pulse oximetry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Aliakbar Sharabiani

Tabriz University of Medical Sciences

sahar.akbari292@gmail.com+98 21 2211 8956

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026