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Peer-reviewedCC BY 4.0European Journal of Pain (London, England)

Pain‐Related Outcome Domains and Measures in Randomized Controlled Trials of Treatment for Acute Abdominal Pain: A Systematic Review

  • Louise Kuhlmann1
  • Cecilie Siggaard Knoph1
  • Søren Schou Olesen1,2
  • Nejo Joseph3
  • John Windsor3
  • Asbjørn M. Drewes1,2
  • Sanjay Pandanaboyana4,5
  • Esther Pogatzki‐Zahn6
6 affiliations
  1. 1Center for Pancreatic Diseases & Mech‐Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital Aalborg Denmark
  2. 2Department of Clinical Medicine Aalborg University Aalborg Denmark
  3. 3Department of Surgery University of Auckland Auckland New Zealand
  4. 4Department of HPB and Transplant Surgery Freeman Hospital Newcastle Upon Tyne UK
  5. 5Population Health Sciences Institute Newcastle University Newcastle UK
  6. 6Department of Anesthesiology, Intensive Care and Pain Medicine University Hospital Muenster Muenster Germany
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Abstract

Background and Objectives: Acute abdominal pain frequently presents to emergency departments, yet outcome domains in randomized controlled trials (RCTs) remain poorly characterized. This review identified pain‐related domains and outcome measures used in RCTs on acute abdominal pain.

Databases and Data Treatment: This PRISMA‐guided systematic review was registered in PROSPERO (CRD42025630171). PubMed, Embase, Scopus, and Web of Science were searched for RCTs (January 2000–February 2025). Eligible studies included adult and paediatric patients with acute abdominal pain reporting pain assessment. Outcome domains extracted included pain intensity, rescue analgesia, adverse effects, pain interference, quality of life (QoL), and psychological function. Bias was assessed using Cochrane RoB2.

Results: Of 826 records, 43 RCTs were included; eight included children. In adult trials, pain intensity was assessed using the visual analogue scale (n = 19) or the numeric rating scale (n = 15). Rescue analgesia (44%) and adverse effects (84%) were frequently reported. No study assessed pain interference or psychological function, and QoL was listed as an outcome in one trial. All were conducted in emergency settings, with short‐term follow‐up within the first hours.

Conclusions: Pain assessment in acute abdominal pain RCTs is predominantly limited to intensity measures and short‐term outcomes. While appropriate for immediate analgesic effects, this approach may be insufficient when broader treatment goals or longer follow‐up are relevant. Context‐specific outcome selection is needed, aligning domains with clinical purpose and time frame.

Significance: RCTs on acute abdominal pain assess pain incompletely, focusing predominantly on intensity rather than broader domains such as pain interference and psychological function. None adhered to the INTEGRATE framework for pain assessment. This review provides the first systematic mapping of outcome domains in this area, offering a foundation for context‐specific outcome selection aligned with what matters to patients.

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Cite

BibTeXRIS
BibTeX
@article{kuhlmann2026painrelated,
  title = {{Pain‐Related Outcome Domains and Measures in Randomized Controlled Trials of Treatment for Acute Abdominal Pain: A Systematic Review}},
  author = {Louise Kuhlmann and Cecilie Siggaard Knoph and Søren Schou Olesen and Nejo Joseph and John Windsor and Asbjørn M. Drewes and Sanjay Pandanaboyana and Esther Pogatzki‐Zahn},
  journal = {European Journal of Pain (London, England)},
  year = {2026},
  month = nov,
  doi = {10.1002/ejp.70445},
  url = {https://doi.org/10.1002/ejp.70445},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Pain‐Related Outcome Domains and Measures in Randomized Controlled Trials of Treatment for Acute Abdominal Pain: A Systematic Review
AU  - Louise Kuhlmann
AU  - Cecilie Siggaard Knoph
AU  - Søren Schou Olesen
AU  - Nejo Joseph
AU  - John Windsor
AU  - Asbjørn M. Drewes
AU  - Sanjay Pandanaboyana
AU  - Esther Pogatzki‐Zahn
PY  - 2026
DA  - 2026/11/04
JO  - European Journal of Pain (London, England)
DO  - 10.1002/ejp.70445
UR  - https://doi.org/10.1002/ejp.70445
AB  - Background and Objectives: Acute abdominal pain frequently presents to emergency departments, yet outcome domains in randomized controlled trials (RCTs) remain poorly characterized. This review identified pain‐related domains and outcome measures used in RCTs on acute abdominal pain.  Databases and Data Treatment: This PRISMA‐guided systematic review was registered in PROSPERO (CRD42025630171). PubMed, Embase, Scopus, and Web of Science were searched for RCTs (January 2000–February 2025). Eligible studies included adult and paediatric patients with acute abdominal pain reporting pain assessment. Outcome domains extracted included pain intensity, rescue analgesia, adverse effects, pain interference, quality of life (QoL), and psychological function. Bias was assessed using Cochrane RoB2.  Results: Of 826 records, 43 RCTs were included; eight included children. In adult trials, pain intensity was assessed using the visual analogue scale (n = 19) or the numeric rating scale (n = 15). Rescue analgesia (44%) and adverse effects (84%) were frequently reported. No study assessed pain interference or psychological function, and QoL was listed as an outcome in one trial. All were conducted in emergency settings, with short‐term follow‐up within the first hours.  Conclusions: Pain assessment in acute abdominal pain RCTs is predominantly limited to intensity measures and short‐term outcomes. While appropriate for immediate analgesic effects, this approach may be insufficient when broader treatment goals or longer follow‐up are relevant. Context‐specific outcome selection is needed, aligning domains with clinical purpose and time frame.  Significance: RCTs on acute abdominal pain assess pain incompletely, focusing predominantly on intensity rather than broader domains such as pain interference and psychological function. None adhered to the INTEGRATE framework for pain assessment. This review provides the first systematic mapping of outcome domains in this area, offering a foundation for context‐specific outcome selection aligned with what matters to patients.
SN  - 1090-3801
SN  - 1532-2149
ER  -