Rectal Thiopental Effects in Pediatric Procedural Sedation and Analgesia

Rectal Thiopental versus Intramuscular Ketamine in Pediatric Procedural Sedation and Analgesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015043012072N4

Enrollment

Registered

2015-05-24

Start date

2012-12-31

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: Wound Repair. Condition 2: Wound Repair. Open wound of scalp Open wound of cheek and temporomandibular area

Interventions

Intervention 1: Intervention group receive sodium thiopental with dose of 25 mg/kg, maximum dose of 1 gram for each child, (dissolved in 10 milliliter of distilled water for rectal administration).

Treatment - Drugs

Intervention group receive sodium thiopental with dose of 25 mg/kg, maximum dose of 1 gram for each child, (dissolved in 10 milliliter of distilled water for rectal administration). For suture hand

Control group recieve hydrochloride ketamine with dose of 2-4 mg/kg (dissolved in 10 milliliter of distilled water for muscular administration). For suture handling, lidocaine (3-5 mg/kg of body weig

Eligibility

Sex/Gender

All

Age

3 Months to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: need sedation for laceration repair; Exclusion Criteria: sensitivity to sodium thiopental or barbiturates; persistent asthma; severe cardiovascular disease; porphyria; contraindications of rectal medications (inflammatory, hemorrhagic, and neoplastic lesions in the intestine); children with airway infection; coronary artery disease; head trauma; eye trauma; central nervous system disease; lack of parents' consent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sedation Efficacy. Timepoint: at start and 30 minute after intervention. Method of measurement: Ramsey score.;Sedation Duration. Timepoint: at start and 30 minute after intervention. Method of measurement: Ramsey score.	—

Secondary

Measure	Time frame
O2 Saturation. Timepoint: at start and 10 minute after intervention. Method of measurement: pulseoxymetery.;Heart Rate. Timepoint: at start and 10 minute after intervention. Method of measurement: heart auscultation.;Respiratory Rate. Timepoint: at start and 10 minute after intervention. Method of measurement: respiratory rate counting.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Esmailian

Isfahan University of Medical Sciences

m_esmailian@med.mui.ac.ir00

Outcome results

None listed

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